Latest news with #LVADs
News18
6 days ago
- Health
- News18
Heart Failure In Your 30s? Understanding The Myths, Risks, And Modern Fixes
Indians are prone to developing heart problems at a younger age compared to those in the West. One of the most common reasons behind this trend is the fast-paced modern lifestyle. If you're in your 20s or 30s, you might only think about your heart during an intense workout or when trying to hit a new personal best. But this tireless muscle works every second of your life, quietly powering your every moment. It deserves more than just an occasional thought. No matter your age, your heart needs consistent care. According to the World Health Organisation, cardiovascular diseases (CVDs) affect around 17.9 million people annually. In India, the situation is particularly alarming: we account for 60% of the world's heart disease cases, and Indians tend to develop heart problems at a younger age than populations in Western countries. Dr. Rajneesh Malhotra, Chairman & Head, Cardio Thoracic and Vascular Surgery, Max Super Speciality Hospital, Saket, Delhi, warns, 'With the speed and direction of our lives in the present time, stressors and cardiovascular diseases can only be anticipated to grow, unless we take a conscious step towards altering the path of our cardiac health." Understanding Heart Failure Heart failure occurs when the heart becomes too weak or stiff to pump blood efficiently. It can result from conditions such as high blood pressure, blocked arteries, heart rhythm problems, or congenital defects. The body tries to compensate by enlarging the heart, pumping faster, or diverting blood to vital organs, but these measures are temporary. In India, younger adults are increasingly affected, often due to lifestyle choices: chronic stress, poor sleep, unhealthy diets, and lack of exercise all contribute to risk. Lifestyle and Medical Interventions Early detection is critical. Managing blood pressure, blood sugar, cholesterol, and stress levels, along with regular exercise and adequate sleep, can dramatically lower the risk. For those already diagnosed, medicines, dietary adjustments, and cardiac rehabilitation programmes can slow disease progression. The Role of Technology For patients with advanced heart failure, a heart transplant is often the gold standard, but long donor waitlists and health constraints limit access. Left Ventricular Assist Devices (LVADs), surgically implanted pumps that help circulate blood, are transforming treatment. Once seen as a short-term 'bridge" to transplant, LVADs are now used as long-term, 'destination" therapy. Recent innovations have made these devices smaller, safer, and more efficient, reducing complications and improving quality of life. Patients can return to many normal activities, with survival rates steadily improving. For many, LVADs offer not just extended life, but renewed independence and hope. First Published: Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
Sydney Morning Herald
09-07-2025
- Health
- Sydney Morning Herald
CorWave device: Australian man receives heart implant at St Vincent's Hospital in world first
Jansz said the two-hour surgery was similar to that required for implant devices currently on the market, but its unique design had the potential to deliver enormous benefits for patients. Loading 'This represents a quantum leap in terms of technology,' he said. 'Very sick patients need a lot of blood flowing around their body … this new [implant] has the ability to pump, not only in a pulsatile manner, but in a greater volume.' The device, which effectively bypasses the failing pump action of the left ventricle, is implanted to act as a bridge to transplantation: keeping the patient alive and well until a donor heart becomes available. Smith is currently living in an apartment close to the hospital. He will return to Leeton in a few weeks, where he is looking forward to catching up with his sons and grandchildren – and getting back on the golf course. 'This transition period with the CorWave allows Michael to get better,' Jansz said. 'His kidneys are working normally, his brain and his heart's working well, he's nourished and he's essentially normal. That's a much better situation to go into a transplant with.' Smith was the first of about 20 patients expected to receive the implant as part of a three-year clinical trial testing the device's efficacy. One other patient has since received the implant at St Vincent's. Mimicking the behaviour of a normally functioning heart, the CorWave's oscillating membrane is driven by a single moving part that automatically adjusts blood flow based on what the patient needs – speeding up when the patient is moving and slowing down at times of rest. This represents a major shift from traditional LVADs, which use a rotating impeller to pump a continuous and fixed flow of blood, without generating a pulse. 'The benefit is that it will be able to respond to exercise more efficiently, and it can be put in sync with the heartbeat … the hope is that will translate to better outcomes for patients,' said Professor Chris Hayward, the senior cardiologist at St Vincent's who led Smith's recovery. Around 144,000 people in Australia live with heart failure, the Australian Institute of Health and Welfare estimates. It was the underlying cause of more than 5000 deaths and contributes to more than 170,000 hospitalisations each year. St Vincent's implants about 60 LVADs a year, Hayward said. The procedure is the latest milestone for the globally renowned team at St Vincent's, who in November implanted the world's first totally artificial heart. The research trial has not received Australian government funding, but the device has attracted significant backing from governments and private investors in Europe. Inspired by the movement of marine animals, the undulating membrane technology was conceived by former triple jumper Jean-Baptiste Drevet, who died in 2022. CorWave chief executive Louis de Lillers said the device was the result of more than a decade of research and development by Paris-based engineers and doctors. 'We owe this moment to the trust of the patient, the excellence of the team at St Vincent's, and the perseverance of our team,' he said. Start the day with a summary of the day's most important and interesting stories, analysis and insights. Sign up for our Morning Edition newsletter.
Yahoo
09-06-2025
- Health
- Yahoo
Microtech Announces the First U.S. Atrial Microsensor Implantations as Part of its FIH Study
TEL AVIV, Israel, June 9, 2025 /PRNewswire/ -- Microtech, a wholly owned subsidiary of Medinol, is happy to announce the first U.S. implantations of its atrial-pressure microsensor. Two surgical implantations were performed on Friday, May 16, 2025, at New York-Presbyterian/Columbia University Irving Medical Center by Dr. Koji Takeda, Surgical Director for Adult Heart Transplant at New York-Presbyterian/Columbia. The Microtech atrial-pressure microsensor is a new class of device, characterized by an extremely small size, entirely passive nature, the absence of any electronics or antenna and its ability to receive and transmit signals via ultrasound. Due to these properties, the Microtech sensors can be used not only as a stand-alone device but can also be integrated onto existing implants, turning them into combination therapeutic-diagnostic smart devices, capable of gathering data and performing multiple functions at once. The two sensors, implanted in patients who received LVADs at New York-Presbyterian/Columbia, join the 5 microsensors already implanted in Israel under similar conditions. "Implantation of the microsensor was easy and took about 5 minutes, requiring a minimal modification to the LVAD implantation procedure," Dr. Takeda said. "The ability to non-invasively monitor both left and right-sided cardiac pressures over time will significantly enhance our ability to optimize care for these patients, allowing us to move past symptoms to parameter-based therapy," said Dr. Nir Uriel, Director of Advanced Heart Failure and Cardiac Transplantation at NewYork-Presbyterian and PI of the Microtech FIH study, adding that, "So far, we've been able to easily, repeatedly and accurately measure these pressures in all patients participating in the study." Dr. Uriel is also an adjunct professor of medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine and a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons. The Microtech FIH study is scheduled to enroll approximately 15 patients in Israel and the U.S. Dr. Yoram Richter, CEO of Medinol, said: "We are thrilled with the study progress and sensor performance thus far and hope that these will continue, allowing us to demonstrate the feasibility, usability and accuracy of this system. Simultaneously, we are working on incorporating microsensors onto existing medical devices, fulfilling the true promise of this technology." About Medinol At Medinol, we are aggressively changing paradigms in how disease states are diagnosed and treated. Whether designing cutting edge devices for stenting multiple areas of the body, dramatically reducing complications in Structural Heart procedures or providing real time insights into the physiological metrics of the human body through implantable sensors, we boldly reassess current technology and procedures and look years into the future to pioneer new devices to broaden the reach of physicians both physically and geographically. Working with our physician and industry partners, Medinol is creating the future today. For more information see or contact Jeff Roach, Chief Commercial Officer at JeffR@ View original content: SOURCE Medinol
Yahoo
19-05-2025
- Business
- Yahoo
U.S. Orphan Designated Drugs Market Research 2025-2030: 500 FDA Designated Orphan Drugs, 400 Marketed Orphan Drugs Pricing & Dosage, 850 Orphan Drugs in Trials
Development of the orphan drug market has contributed to the rise in collaborations between pharmaceutical firms. Collaborations can assist in the division of the cost and the acceleration of the development of new medicines. An example is the partnership between Cadrenal Therapeutics and Abbott, established in March 2025 to aid in the development of tecarfarin, a new oral anticoagulant, in patients with HeartMate 3T Left Ventricular Assist Devices (LVADs). Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "U.S. Orphan Designated Drugs Market Opportunity, Drugs Sales, Price, Dosage & Clinical Trials Insight 2030" report has been added to offering. U.S. market for orphan drugs will continue to grow. The regulatory environment will continue to shift to facilitate orphan drug development, with increasingly streamlined approval procedures and additional incentives to stimulate innovation. As rare diseases are increasingly well understood, and as advances in science offer new means of attacking them, the market for orphan drugs will increasingly be characterized by diversity in the types of diseases being treated. There is also increased awareness that rare diseases tend to have common molecular mechanisms, raising the possibility that treatments applicable across larger groups could be developed. Development of the orphan drug market has contributed to the rise in collaborations between pharmaceutical firms. Collaborations can assist in the division of the cost and the acceleration of the development of new medicines. An example is the partnership between Cadrenal Therapeutics and Abbott, established in March 2025 to aid in the development of tecarfarin, a new oral anticoagulant, in patients with HeartMate 3T Left Ventricular Assist Devices (LVADs). Tecarfarin, granted orphan drug status, is under investigation in a clinical trial for enhancing anticoagulation benefit in patients with advanced heart failure. This alliance reflects the increased trend of grouping together resources and expertise to make therapies for rare conditions, as the scientific and logistical hurdles associated with orphan drug development can be significant. More drugs have over the years acquired orphan drug status. To date, hundreds of drugs in development have been assigned such status with the indications ranging from rare tumors to genetic conditions, cardiovascular diseases, and neurologic conditions. The FDA orphan drug designation not only encouraged the development of novel treatments but also has resulted in some unexpected commercial success stories. Those drugs initially designed for limited patient populations now are showing to be profitable products, reversing the opinion that orphan drugs cannot exhibit good market performance. One of the best examples is Merck's Keytruda (pembrolizumab), an immune checkpoint inhibitor that originally received orphan drug designation in 2012 for malignant melanoma. Since then, Keytruda has had its indications broadened to include various cancers, such as esophageal carcinoma, lymphoma, and lung cancer, among others, many of which are orphan diseases. Although an orphan drug, Keytruda is now amongst the world's best-selling cancer medications, with 2024 revenue of almost U.S.$ 29.4 billion, an astonishing 18% increase over last year. Importantly, more than 60% of this originated from the U.S. alone. This business success demonstrates how orphan drugs, in the long run, can discover larger markets and generate sizeable returns. Likewise, Gilead's Biktarvy, an HIV drug, was given orphan drug designation and is now one of the company's best-selling drugs. In 2024, it recorded U.S.$ 13.4 billion in sales, up 13% from the previous year. Both drugs underscore how treatments for rare diseases can evolve from specialty therapies into big moneymakers. The success of these drugs in the market shows that orphan drug development can be both clinically effective and profitable. With appropriate incentives, companies are more likely to invest in the treatment of rare diseases, even if the number of patients is small. The incentives created by the FDA and other regulatory authorities, including the potential for market exclusivity and fast-track review, enable firms to break even on their investment and reap huge profits in the long term. These advantages have motivated numerous firms to enter the orphan drug area, particularly since rare diseases are increasingly being understood as a result of advances in genomics and biotechnology. Report Offering & Highlights: U.S. Orphan Designated Drugs Market Opportunity: > U.S.$ 190 Billion by 2030 Insight on FDA Designated Orphan Drugs in Clinical Trials: > 850 Orphan Drugs Clinical Trials Insight by Company, Indication, Phase & Priority Status Insight on FDA Designated Marketed Orphan Drugs: > 500 Orphan Drugs Pricing & Dosage Insight: > 400 Marketed Orphan Drugs U.S., Global, Regional, Annual Sales Insight (2019 - Q1'2025): >150 Orphan Drugs Sales, Price & Dosage Data Represented in More Than 1000 Charts & Tables Orphan Designation Insight by Indication, Company, Trial Phase, Marketed Drugs Represented in 1000 Tables Key Topics Covered: 1. FDA Orphan Designation Criteria & Market Exclusivity 2. US Orphan Designated Drugs Market Insight2.1 Current Market Overview2.2 Future Market Opportunity Assessment 3. US Orphan Designated Drugs Market Trends by Indication3.1 Cancer3.2 Neurological Disorders3.3 Cardiovascular Disorders3.4 Ophthalmic Diseases3.5 Rare Genetic Disorders & Metabolic Disorders3.6 Autoimmune & Inflammatory Diseases 4. US Orphan Designated Drugs Reimbursement Scenario4.1 Medicare4.2 Medicaid4.3 Private Insurers4.4 Pharmaceutical Companies 5. US Orphan Designated Drugs Clinical Trials Insight5.1 by Patient Segment5.2 by Phase5.3 by Priority Status 6. US Orphan Designated Drugs Clinical Trials by Company, Indication & Phase6.1 Research6.2 Preclinical6.3 Phase-I6.4 Phase-I/II6.5 Phase-II6.6 Phase-II/III6.7 Phase-III6.8 Preregistration6.9 Registered 7. Marketed Orphan Designated Drugs Clinical Insight by Company & Indication 8. US Orphan Designated Drugs Dosage, Price & Treatment Cost Insight8.1 Lynparza8.2 Nplate8.3 Tafinlar8.4 Halaven8.5 Jadenu8.6 Xpovio8.427 Ojemda8.428 Ojjaara8.429 Piasky8.430 Rezurock8.431 Pombiliti8.432 Ogsiveo8.433 Qfitlia8.434 Zevaskyn 9. US Orphan Designated Drugs Sales Insight (2019 - Q1'2025)9.1 Amvuttra9.2 Krazati9.3 Tecvayli9.4 Imjudo9.5 Rezurock9.6 Elrexfio9.7 Fabhalta9.154 Xospata9.155 Defitelio9.156 ReFacto9.157 Praluent9.158 Mozobil9.159 Yescarta9.160 Lunsumio9.161 Keytruda9.162 Pemazyre9.163 Camzyos 10. Competitive Landscape10.1 AbbVie10.2 Alexion AstraZeneca Rare Disease10.3 Alnylam Pharmaceuticals10.4 Amgen10.5 Amicus Therapeutics10.6 Array BioPharma10.7 Astellas Pharma10.8 AstraZeneca10.9 Bayer HealthCare10.10 BioMarin Pharmaceutical10.11 Bioverativ10.12 Boehringer Ingelheim10.13 Bristol-Myers Squibb10.14 Chiesi10.15 Chugai Pharmaceutical10.16 Collaborations Pharmaceuticals10.17 CSL10.18 Daiichi Sankyo Company10.19 Eisai Co Ltd10.20 Eli Lilly & Company10.21 Emergent BioSolutions10.22 Ferring Pharmaceuticals10.23 Flavocure Biotech10.24 Genentech10.25 Genmab10.26 Gilead Sciences10.27 GSK10.28 Hanmi Pharmaceutical10.29 Horizon Therapeutics plc10.30 Incyte Corporation10.31 Ionis Pharmaceuticals10.32 Ipsen10.33 Janssen Biotech10.34 Jazz Pharmaceuticals plc10.35 Johnson & Johnson10.36 Kamada10.37 Krystal Biotech10.38 Kyowa Kirin10.39 Leadiant Biosciences10.40 Ligand Pharmaceuticals10.41 Lundbeck A/S10.42 MeiraGTx10.43 Merck10.44 Moderna Therapeutics10.45 Novartis10.46 Novo Nordisk10.47 Omeros Corporation10.48 Onyx Pharmaceuticals (Amgen)10.49 Otsuka Pharmaceutical10.50 Pfizer10.51 PTC Therapeutics10.52 Recordati10.53 Regeneron Pharmaceuticals10.54 Roche10.55 Sanofi10.56 Servier10.57 Shionogi10.58 Spark Therapeutics10.59 Sumitomo Pharma10.60 Sutro Biopharma10.61 Swedish Orphan Biovitrum10.62 Takeda10.63 Teva Pharmaceutical Industries10.64 UCB10.65 UniQure10.66 Vertex Pharmaceuticals10.67 XOMA10.68 ZymoGenetics (BMS) For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Business Wire
15-05-2025
- Business
- Business Wire
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla.--(BUSINESS WIRE)-- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. 'We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,' said Quang X. Pham, Chairman & CEO. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib). Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements.' The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potentially,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
