Latest news with #Johnson&JohnsonMedTech
Yahoo
29-07-2025
- Business
- Yahoo
Johnson & Johnson Launches VIRTUGUIDE™ AI-Powered Patient-Matched Lapidus System in U.S. to Reduce Complexity in Bunion Surgery for Millions
Early VIRTUGUIDE™ surgeons report a 30-minute reduction in surgical time versus traditional treatment1,2,*,** WEST CHESTER, Penn., July 29, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Johnson & Johnson MedTech, a global leader in orthopaedic technologies and solutions, today announced the launch of the VIRTUGUIDE™ System. This AI-powered, patient-matched solution is designed to support Lapidus procedures2, a type of bunion surgery that helps realign the foot by joining two bones near the arch (the first metatarsal bone and the medial cuneiform).3 The system uses pre-operative planning software, developed in collaboration with PeekMed®, to assess each patient's bunion and make personalized recommendations for the intended correction.2 Bunions are among the most common foot problems, affecting nearly one-third of adults in the U.S.4, yet traditional Lapidus surgery to treat the condition is often challenging.5,6 The VIRTUGUIDE™ AI Lapidus System addresses this by enabling a streamlined approach and reducing surgical complexity.2** Early users estimated procedural time savings of at least 30 minutes when using the system compared to their previous technique.1,* "VIRTUGUIDE™ has completely transformed my approach to bunion surgery, making a complex Lapidus procedure significantly easier and faster. Since adopting VIRTUGUIDE™, my surgical corrections have been spot-on—what I plan preoperatively is exactly what I achieve in the operating room," said Michael Campbell, M.D., FAAOS, a board-certified orthopaedic surgeon at Atlantic Orthopaedic Specialists.± "This improved accuracy leads to better outcomes, and the ability to present the pre-operative plan to my patients helps address their questions and ease their concerns§." "The VIRTUGUIDE™ System is a pivotal advancement in AI-powered surgical precision for treating bunion deformities—a common, painful, and potentially debilitating condition affecting nearly one-third of Americans4," said Oray Boston, Worldwide President of Trauma, Extremities, Craniomaxillofacial, Animal Health and Sports Medicine, Orthopaedics, Johnson & Johnson MedTech. "This milestone marks an important step forward, as VIRTUGUIDE™ becomes the latest addition to our growing portfolio of VELYS™ Enabling Tech solutions. By automating surgical planning and tailoring instrumentation to each patient, the system helps reduce complexity in the operating room and helps surgeons to achieve the intended correction2,7**." This launch follows the 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Pre-operative Planning Software, granted earlier this year.‖ The system is now available in the U.S. For more information, visit Orthopaedic Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. In Orthopaedics, we are on a mission to keep people moving by leveraging our deep expertise in joint reconstruction, robotics and enabling tech, spine, sports, trauma, and extremities, to develop the next generation of medtech solutions. We offer one of the most comprehensive Orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. For more, visit our website or follow us on LinkedIn. About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at Follow us at @JNJMedTech and on LinkedIn. DePuy Synthes Products, Inc. is a Johnson & Johnson company. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VIRTUGUIDE™ System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Important Information: Prior to use, refer to the instructions for use supplied with the device(s) or indications, contraindications, warnings and precautions. © Johnson & Johnson and its affiliates 2025. All rights reserved. US_ORT_FTAK_398543 * Statements are based on responses from 10 surgeons, having completed a total of 150 Lapidus procedures using the VIRTUGUIDE™ System. The statements reflect surgeon experience, not clinical outcomes, and were included if at least 6 surgeons agreed.** VIRTUGUIDE™ System compared to Treace Medical Lapiplasty® 3-Plane System and Paragon28 Bun-Yo-Matic Lapidus Clamp System.± Dr. Michael Campbell, M.D., FAAOS is a paid consultant for Johnson & Johnson MedTech.§These statements reflect the experience, approach and opinion of the surgeon.‖ The VIRTUGUIDE™ Planning Software, powered by PeekMed®, is developed and owned by Peek Health, S.A. Refer to for user manuals, FAQ's, or any support. The third-party trademarks used herein are trademarks of their respective owners. 1 Johnson & Johnson MedTech, VIRTUGUIDE™ System Early Surgeon Experience Report December 2024, Windchill Document# EM24-00282 Johnson & Johnson and its affiliates VIRTUGUIDE™ System Feature Memo. 9th Dec 2024. Windchill # EM24-0027. 3 American Orthopaedic Foot & Ankle Society. Lapidus Procedure. FootCareMD. Accessed June 24, 2025. 4 MedlinePlus. Bunion: Genetic and Environmental Causes. U.S. National Library of Medicine. Available at Accessed March 2025.5 Rupke T. The modified Lapidus procedure for the treatment of moderate to severe hallux valgus. Orthogate. Published October 30, 2013. Accessed June 26, 2025. Foran IM, Lin J, Hamid KS, Lee S. Technical tip: kerfing for Lapidus arthrodesis: deformity correction with minimal bone resection. J Foot Ankle Surg. 2021;60(2):424-427. doi:10.1053/ 7 Sobrón FB, Santos-Vaquinhas AD, Alonso B, et al. Technique tip: 3D printing surgical guide for pes cavus midfoot osteotomy. J Foot and Ankle Surgery. 2022;28:371-377. Media Contacts:Erin Farley efarley1@ Abhi Basuabasu26@ Investor Contact:investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson MedTech Sign in to access your portfolio
Yahoo
22-07-2025
- Business
- Yahoo
Pacira BioSciences Announces Strategic Collaboration to Significantly Expand ZILRETTA Promotional Efforts
Partnership expected to advance 5x30 strategy by increasing ZILRETTA sales calls and extensively expanding patient access BRISBANE, CA, July 22, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced a strategic collaboration1 with Johnson & Johnson MedTech to significantly expand the market reach of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), leveraging its specialized early intervention sales force to co-promote the treatment to existing and new customers. ZILRETTA is Pacira's extended-release treatment for osteoarthritis knee pain. This agreement is expected to significantly expand access and extend reach across a large portion of the seven million intra-articular knee injections administered to patients annually in the U.S. 'This partnership embodies our 5x30 strategy of leveraging innovative, targeted collaborations that drive growth, enhance our commercial presence, and improve the patient journey with safe, effective non-opioid treatments," said Frank D. Lee, chief executive officer of Pacira BioSciences. 'With its proven long-lasting benefits and distinct mechanism of action, ZILRETTA is uniquely positioned to meet a critical need in osteoarthritis pain management, and we believe this agreement will allow us to reach even more patients across the country,' added Mr. Lee. With a significantly expanded promotional effort through a collaboration with Johnson & Johnson MedTech's early intervention sales force, which currently promotes hyaluronic acid injections for osteoarthritis knee pain, this team now has the opportunity to support individualized pain management based on patient needs and preferences. This collaboration extends the reach of ZILRETTA beyond orthopedic practices into additional physician specialties, including sports medicine, pain management and rheumatology. About PaciraPacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®°, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit About ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) On October 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis (OA)- related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at Indication and Select Important Safety Information for ZILRETTA Indication: ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee. Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product. Warnings and Precautions: Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration. Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use. Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs. Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment. Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions. Please see for full Prescribing Information. Forward-Looking StatementsAny statements in this press release about Pacira's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words 'anticipate,' 'believe,' 'can,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'project,' 'should,' 'will,' 'would,' and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: '5x30', our growth and business strategy, our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation ('NOPAIN') Act, the expected cost savings and benefits of the July 2025 reduction in force and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome ('pMVL') drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company; the anticipated funding or benefits of our share repurchase program; and factors discussed in the 'Risk Factors' of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the 'SEC'). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. 1 Co-Promotion Agreement between Pacira Pharmaceuticals Inc. and DePuy Synthes Sales, Inc. CONTACT: Investor Contact: Susan Mesco, (973) 451-4030 Media Contact: Sara Marino, (973) 370-5430 in to access your portfolio
Korea Herald
08-07-2025
- Health
- Korea Herald
Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment
The VARIPULSE™ Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy. 1,i,ii,iii,iv,v,vi,vii,viii,ix The VARIPULSE™ Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea. IRVINE, Calif., July 8, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria. x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors. x,xi It significantly increases the risk of stroke, heart failure, and mortality. The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib) xii. It enables safe and efficient i,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurex iii,xiv,xv and is compatible with deep and/or conscious sedation. 2,xvi,xvii This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform: "The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care," stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, Asia Pacific. "The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes." Atrial Fibrillation affects over 16 million people in Asia-Pacific xxi. Symptoms and clinical consequences of AFib disrupt patient's quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizziness xxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortality xxiii. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve. "PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients" said Dr. Yasuo Okumura 7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. "PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients." About the VARIPULSE™ Platform The VARIPULSE™ Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada. Cardiovascular Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. Cautions Concerning Forward-Looking Statements: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012
Malaysian Reserve
08-07-2025
- Business
- Malaysian Reserve
Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment
The VARIPULSE™ Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.1,i,ii,iii,iv,v,vi,vii,viii,ix The VARIPULSE™ Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea. IRVINE, Calif., July 8, 2025 /PRNewswire/ — Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.x,xi It significantly increases the risk of stroke, heart failure, and mortality. The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib)xii. It enables safe and efficienti,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurexiii,xiv,xv and is compatible with deep and/or conscious sedation.2,xvi,xvii This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform: In inspIRE, 80% of patients achieved freedom from recurrence with zero primary adverse In admIRE, results showed a 75% overall primary effectiveness success rate3, a 2.9% primary adverse event rate4,xix, 100% of patients achieved acute procedural success5, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy6. In the ongoing VARIPURE registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasmsxx. 'The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care,' stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, Asia Pacific. 'The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes.' Atrial Fibrillation affects over 16 million people in Asia-Pacificxxi. Symptoms and clinical consequences of AFib disrupt patient's quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizzinessxxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortalityxxiii. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve. 'PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients' said Dr. Yasuo Okumura7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. 'PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients.' About the VARIPULSE™ PlatformThe VARIPULSE™ Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada. Cardiovascular Solutions from Johnson & Johnson MedTechAcross Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. Cautions Concerning Forward-Looking Statements: This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE™ Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012 ________________________________________ 1 When compared to procedures that did not use navigation systems. 2 Based on a subset of 29 deep sedation patients from the inspIRE study and 60 patients in inspIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency. 3 Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]/atrial flutter [AF]) episodes of ≥30 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; >1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I/III AADs at greater doses during the evaluation period; continuous AF/AT/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF/AT/AFL recurrences. The protocol defined performance goal is 50%. 4 Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%. 5 Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255). 6 Visualization performed with ICE and the CARTO™ 3 System. 7 Dr. Okumura serves as a consultant for Johnson & Johnson but was not compensated for this announcement ________________________________________ i Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023;16(3):e011780. doi:10.1161/CIRCEP.122.011780 pg 4 ii Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8 iii Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303–2310 (2024). pg 2 iv Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016/ PMID: 37323994; PMCID: PMC10264259. Pg 6 v VOLT CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3 vi Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093/europace/euaf012. Pg 4 results section vii Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1 viii Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197 ix Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111/pace.15177. Epub ahead of print. PMID: 40153431. x Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland xi Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517 xii Di Biase L, Zou F, Lin AN, et al. Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211. xiii Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783 xiv Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8. xv Tahin T, Riba A, Nemeth B, et al. (2021). 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Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320. xviii Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston. xix Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333. xx Bessière F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA. xxi Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from xxii American Heart Association . (2024, August 12). What are the symptoms of atrial fibrillation?. xxiii Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161/CIR.0000000000001193 Media contacts:Carlos Taveras Ctaveras@ FarleyEfarley1@ View original content:
Glasgow Times
02-07-2025
- Health
- Glasgow Times
Ross Hall Hospital rolls out robotic knee surgery system
Ross Hall Hospital, part of Circle Health Group, is said to be the only private hospital in Scotland to offer the VELYS Robotic-Assisted Solution. Developed by Johnson & Johnson MedTech, the system is designed to improve patient outcomes with shorter hospital stays and greater post-surgery mobility. Mhairi Jefferies, executive director of Ross Hall Hospital, said: "We are delighted to be working with Johnson & Johnson MedTech to deploy the VELYS system at Ross Hall Hospital. Read more: Vile rapist sentenced after preying on two young girls "We know our patients are looking for faster recovery times and an improved quality of life post-surgery. "The arrival of this system promises to offer our patients the latest and best technology on their doorstep." The VELYS system works exclusively with the ATTUNE Knee System and is designed to improve post-operative stability and movement by preserving soft tissue around the knee joint. It uses CT-free technology to assist surgeons in placing implants more accurately, aiming for more predictable outcomes and a quicker return to mobility. The first procedure using the new technology was carried out on April 23.
