Latest news with #BostonScientific
Yahoo
a day ago
- Business
- Yahoo
Boston Scientific ends TAVR sales; J&J shares Monarch robot data
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Boston Scientific said Wednesday it plans to end worldwide sales of its transcatheter aortic valve replacement systems, citing regulatory hurdles. The company will discontinue its Acurate Neo2 and Acurate Prime TAVR systems, which are sold in Europe, and will not pursue Food and Drug Administration approval for the devices. Boston Scientific said in a regulatory filing that the decision followed recent discussions with regulators, adding that the products faced increased requirements to maintain approvals in global markets and to obtain approvals in new regions. The company had told investors the 'path to approval in the U.S. was unclear and the approval requirements in Europe would be even greater,' Needham analyst Mike Matson wrote in a research note Wednesday. The decision followed Boston Scientific missing its primary endpoint in a trial comparing its Acurate Neo2 device to other TAVR systems. The Acurate business brought in about $200 million in sales last year, Matson wrote. 'Given the product's mixed clinical track record and complicated path to US approval, we're not surprised by Boston's choice to discontinue the product and redirect its time, effort, and dollars elsewhere,' J.P. Morgan analyst Robbie Marcus wrote in a research note. Marcus views the decision as the right strategy for Boston Scientific, even if the company takes a hit in the short term. Johnson & Johnson shared results of a study that found the company's Monarch bronchoscopy robot was able to reach small, peripheral lung nodules in more than 98% of cases. The robotic platform was able to locate and biopsy the nodules with a safety rate comparable to non-robotic bronchoscopy techniques, the company said in a Wednesday announcement. The TARGET study was published in Chest Journal on April 26 and was sponsored by J&J subsidiary Auris Health. The single-arm trial enrolled 679 people in the U.S., Canada and Hong Kong. Auris first received FDA clearance for the Monarch robot in 2018. J&J acquired the company a year later for $3.4 billion in cash. A software update for the system, intended to improve accuracy in reaching suspicious nodules, was cleared in March. Medtronic said Tuesday that a technology it is developing for its pulse oximeters was accepted into the FDA's Safer Technologies Program. The program is intended to support expedited development, assessment and review of devices that are expected to improve the safety of currently available devices. Medtronic is developing a technology to integrate patient- and sensor-specific data into oxygen saturation calculations used by its Nellcor pulse oximeters. Pulse oximeters have faced recent scrutiny by the FDA after studies have shown the devices may be less accurate for people with darker skin pigmentation. The agency issued a draft guidance in January updating testing recommendations for the devices, but it has not yet finalized the guidance. Last year, Medtronic agreed to provide labels and brochures to California hospital customers about the potential for flawed readings as part of a settlement with Roots Community Health, which sued 13 companies that make or sell pulse oximeters over the risk of disparities in treatment. Recommended Reading Edwards gains expanded TAVR label for asymptomatic patients Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
a day ago
- Business
- Medscape
ACURATE Heart Valves Halted After Consequential Study
Boston Scientific has discontinued production of its ACURATE neo2 heart valves following the release of data showing the devices were linked to higher rates of all-cause death, stroke, and rehospitalization than were other commercially available valves. The company reported the decision in a May 28 regulatory filing. 'While data continue to support the performance of the ACURATE valve system when the product's optimized instructions for use are followed, this decision was made based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets,' Boston Scientific told Cardiovascular Business . 'Therefore, related commercial, clinical, research and development, and manufacturing activities will cease.' The company said it also would be halting production of its ACURATE PRIME valves, although the reason for that move was not clear. Disappointing Results The decision on the neo2 follows the publication May 21 of two articles from the study, one in the Lancet on the outcomes for patients and the other in the Journal of the American College of Cardiology on a relatively high rate of under-expansion of the valves. Despite its use in 50 other countries, ACURATE neo2 had not yet been approved by the US Food and Drug Administration. The Lancet study, which the company funded, involved 1469 patients undergoing transcatheter aortic valve replacement (TAVR). Its aim was to determine whether ACURATE neo2 was not inferior to its competitors. The randomized, controlled trial found ACURATE neo2 was associated with a 6.6% higher rate of a combined outcome of all-cause death, stroke, and rehospitalization after 1 year than was observed in a control group who received SAPIEN 3 or 3 Ultra or Evolut valves. The rates were also higher for each outcome (hazard ratio: 1.30 for all-cause death, 1.68 for stroke, and 1.57 for rehospitalization). Rates of cardiovascular mortality and myocardial infarction also were significantly higher at the same time point, according to the researchers. ACURATE neo2 was developed after its predecessor, ACURATE neo, a self-expanding valve for TAVR, did not achieve outcomes similar to those of SAPIEN and Evolut valves in randomized controlled trials. A problem with paravalvular leakage was found with ACURATE neo, prompting the development of neo2, which included a sealing skirt to prevent leakage, said Raj Makkar, MD, professor and associate director of the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, and lead author of both papers. 'The sealing skirt worked, and the valvular regurgitation rates were lower than in ACURATE neo, but they were nonetheless still higher than in the control valves,' said, who receives research support from Boston Scientific as well as other manufacturers of heart valves. In addition to poor results on the longer-term outcomes, the ACURATE neo2 was associated with a lower rate of success, determined by whether the device was installed and operated successfully, did not require further interventions, and was not linked to complications within 30 days. One result was positive for ACURATE neo2. 'The hemodynamics were actually quite good,' Makkar said. 'This trial also highlights that, when it comes to clinical outcomes, it's not just the hemodynamics. A lot of other things come into play.' 'The ACURATE neo2 valve is an easy-to-use valve, and smaller, observational studies had suggested that outcomes were good,' Makkar added. 'But you need the rigor of a randomized controlled trial. In a randomized setting, the clinical outcomes were not as robust as they were with the other valve platforms.' Valve Expansion a Concern In a post-study analysis, the researchers went back to see if they could find any contributing factors to the ACURATE neo2's poorer outcomes. When they reviewed angiograms taken during TAVR procedures, they noticed many of the valves had not fully expanded. 'We found that under-expansion was associated with more frequent primary endpoints in contrast to valves that were properly expanded,' Makkar said. 'If you modified the device such that the radial strength were better, and we did more aggressive pre- and post-dilation, we could perhaps improve the expansion of the valve,' Makkar said. 'But whether that would lead to better clinical outcomes remains to be investigated and proven…. Dilation might increase the risk of some complications, such as stroke and aortic root injury. It is reasonable to try to safely expand the valve, but we should not expand the valve at any cost.' Makkar reported research support from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and JenaValve.
Yahoo
6 days ago
- Business
- Yahoo
CooperCompanies (COO) To Report Earnings Tomorrow: Here Is What To Expect
Medical device company CooperCompanies (NASDAQ:COO) will be reporting results tomorrow afternoon. Here's what to look for. CooperCompanies missed analysts' revenue expectations by 1.5% last quarter, reporting revenues of $964.7 million, up 3.6% year on year. It was a slower quarter for the company, with a slight miss of analysts' organic revenue estimates and full-year revenue guidance meeting analysts' expectations. Is CooperCompanies a buy or sell going into earnings? Read our full analysis here, it's free. This quarter, analysts are expecting CooperCompanies's revenue to grow 5.5% year on year to $994.1 million, slowing from the 7.4% increase it recorded in the same quarter last year. Adjusted earnings are expected to come in at $0.93 per share. Analysts covering the company have generally reconfirmed their estimates over the last 30 days, suggesting they anticipate the business to stay the course heading into earnings. CooperCompanies has missed Wall Street's revenue estimates five times over the last two years. Looking at CooperCompanies's peers in the medical devices & supplies - diversified segment, some have already reported their Q1 results, giving us a hint as to what we can expect. Boston Scientific delivered year-on-year revenue growth of 20.9%, beating analysts' expectations by 2%, and Baxter reported revenues up 5.4%, topping estimates by 1.9%. Boston Scientific traded up 6.5% following the results while Baxter was down 1.5%. Read our full analysis of Boston Scientific's results here and Baxter's results here. Investors in the medical devices & supplies - diversified segment have had steady hands going into earnings, with share prices flat over the last month. CooperCompanies is down 2% during the same time and is heading into earnings with an average analyst price target of $105.55 (compared to the current share price of $80.59). When a company has more cash than it knows what to do with, buying back its own shares can make a lot of sense–as long as the price is right. Luckily, we've found one, a low-priced stock that is gushing free cash flow AND buying back shares. Click here to claim your Special Free Report on a fallen angel growth story that is already recovering from a setback. Sign in to access your portfolio
Reuters
6 days ago
- Business
- Reuters
Boston Scientific to stop heart device sales, not seek new approvals
May 28 (Reuters) - Boston Scientific (BSX.N), opens new tab said on Wednesday it has stopped global sales of its heart device and will not seek approval in geographies it is not yet available due to increased clinical and regulatory requirements. Shares of the device maker fell 1.5% to $104.57 in premarket trading. The devices, called transcatheter aortic valve replacement (TAVR), had obtained the European Union's CE-mark and were sold under the brands Acurate Prime and Acurate neo2 for minimally invasive heart surgeries. But the company said recent discussions with U.S. and other regulators resulted in increased requirements to maintain regulatory approvals in existing and new markets. "The resources and investments necessary to meet these new requirements are prohibitive," the company said. The company expects to meet second quarter and full-year outlook despite the anticipated financial hit from the decision, Boston said, adding that it has not reaffirmed the outlook.
Yahoo
25-05-2025
- Health
- Yahoo
Mon Medical Center achieves state first in new AFib procedure
May 25—dbeard @ Vandalia Health Mon Medical Center recently achieved another first-in-state in heart care by combining two technologies to treat atrial fibrillation — AFib. Mon Health Heart & Vascular Center electrophysiologist Dr. Salam Sbaity and his team combined the application of the Watchman and the Farapulse Pulsed Field Ablation system — both from Boston Scientific — in a single procedure. AFIb is when the top two chambers of the heart — the atria — beat too fast and with an irregular rhythm (fibrillation), Boston Scientific said. Sbaity explained why combining the two technologies is significant. AFib is the most common abnormal heart rhythm and West Virginia is among the top three states for prevalence. AFib symptoms include palpitations, dizziness and shortness of breath, he said, and can lead to heart failure, blood clots and stroke. There are two main advanced treatments. One is to treat the source of clots and stroke by closing the left atrial appendage, which extends off of the left atrium. The Watchman device is used to close it off. The other is to treat the rhythm itself, he said. Muscle sleeves lead from the atrium into four pulmonary veins and are the source of electrical instability that can start the abnormal rhythm. The abnormal rhythm is treated via cauterization, also known as ablation. The two forms of ablation used are extreme heat — radio frequency ablation — and extreme cold, cryoablation. Boston Scientific announced in January 2024 that the FDA approved a new form, pulsed field ablation, with the Farapulse. The Farapulse catheter is tipped with five circular splines that can change shapes — including a flower — to fit into the entry of veins, circle and isolate them. The Farapulse uses electrical pulses to create pores in the cell membranes and the cells die without heat or freezing, Sbaity said. It's safe for the structure of the veins and structures around them. Boston Scientific reported that 12-month data from a pivotal clinical trial to directly compare the efficacy and safety of the Farapulse system against standard-of-care ablation found that Farapulse therapy was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quicker learning curve for physicians. "That made the procedure itself more effective and more safe, " he said. Sbaity and his partner, Dr. Matt Gaskill, performed the first Farapulse procedure in the state. "In reviewing the literature for a while, we were seeing that this is the future of ablation." It's faster, more effective and safer, he said. Both are done via a catheter through the groin and into the same chamber of the heart. So it allows the flexibility to add another procedure without increasing time and risks. The dual procedure has to be guided by internal imaging, and Sbaity took a further advanced step by employing intracardiac ultrasound — also called intracardiac echocardiography, ICE — instead of the usual transesophageal echocardiography, TEE. TEE requires a second physician sending a scope down the throat, posing the risk of esophageal damage, the American Heart Association says. ICE can be performed by the primary physician doing the catheter procedure, avoiding the additional intubation and damage risks. Only 8 % of cases of appendage closure in country are done with ICE, Sbaity said. Combining the two procedures, Sbaity said, allows him to offer the patient advanced treatment of both problems, with the risks associated with separate procedures pared down to one, and with reduced recovery time. I think this is the wave of the future, combining the two procedures together whenever both are necessary, " he said. The Mon team is participating in clinical trials comparing appendage closure against blood thinners for people who are not having problems with blood thinners, he said. One study showed closure is better statistically and better in terms of risks. "I think the other two studies will probably prove the same." What that means, he said, "if it goes that way, then anyone on blood thinner who goes for an ablation would as well want to close the appendage." This would increase the number of patients who benefit from the combined procedure. He expects most patients will want it. Sbaity said he has done just the one combined procedure so far, but five more are scheduled. "We're proud here at Mon to offer the most advanced technologies for our patients in West Virginia, " he said, "and we always want to be and have been at the forefront of innovation. That allows the population of West Virginia to have access to the most excellent, best care in the country."
