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Total 36 results found since Jan 2013.

Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device
Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday. Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approv...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news

TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation. Five-year data from the Prevail study was published online today in the Journal of the American College of Cardiology. In both trials, the Marlborough, Mass.-based company compared the Watchman device to warfarin treatment for stroke prevention in patients with non-valvular AF with follow-ups out to five years. A combined an...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news

Abstract 198: Racial Disparity In Resuming Anticoagulation For Atrial Fibrillation After An Episode Of Major Gastrointestinal Bleeding Poster Session II
Conclusion: In conclusion, the racial disparity in resuming warfarin after an episode of major GIB in anticoagulated patients for atrial fibrillation was more for Caucasians than African American. This may be explained by uncertainty of outcomes that frequently leads to overtreatment of minority patients. Cultural beliefs for not resuming warfarin might have also played a role.
Source: Circulation: Cardiovascular Quality and Outcomes - May 15, 2013 Category: Cardiology Authors: Qureshi, W., Garikapati, K., Patsias, I., Cheema, G., Mittal, C., Alirhayim, Z., Paje, D. Tags: Poster Session II Source Type: research

Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer. Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset of the patients who currently would be eligible for the device under the FDA-approved label,” or patients at high risk for stroke and bleeding and/or contraindicated to long-term warfarin use. “Whi...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Source Type: news

MassDevice.com +3 | The top 3 medtech stories for November 24, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.   3. Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo Ocular Therapeutix said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Th...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Link between indigestion drugs and dementia 'inconclusive'
Conclusion This study found people taking PPIs had a 44% higher risk of developing dementia in a seven-year period compared with those not taking the drugs. However, it's not accurate to say this was down to the PPIs – the study couldn't prove this, and there are many possible explanations. For a start, the groups weren't very similar. Those taking PPIs had poorer health, and were more likely to be taking a number of medicines and have conditions linked to a higher risk of dementia, such as diabetes and heart disease. After taking these factors into account in the analysis, the link between PPIs and dementia reduc...
Source: NHS News Feed - February 16, 2016 Category: Consumer Health News Tags: Medication Neurology Older people Source Type: news

Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.
Abstract IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on treatment. The underlying thesis was that patients could be change agents to initiate prescribing discussions with their providers. We tested the effect of mailing information to both patients and their providers. We used administrative medical claims and pharmacy dispensing data to identify eligible patients, to randomize them to an early or delayed interve...
Source: Clinical Trials - June 25, 2020 Category: Research Authors: Garcia CJ, Haynes K, Pokorney SD, Lin ND, McMahill-Walraven C, Nair V, Parlett L, Martin D, Al-Khalidi HR, McCall D, Granger CB, Platt R, Cocoros NM Tags: Clin Trials Source Type: research

Partial upper sternotomy for aortic valve replacement provides similar mid-term outcomes as the full sternotomy
CONCLUSIONS: Upper partial sternotomy can be performed safely for aortic valve replacement, without increased risk of death, stroke or re-admission in 3 years postoperatively.PMID:35572904 | PMC:PMC9096275 | DOI:10.21037/jtd-21-1494
Source: Journal of Thoracic Disease - May 16, 2022 Category: Respiratory Medicine Authors: Jan Hlavicka David Janda Petr Budera Petr Tousek Marek Maly Richard Fojt Hana Linkova Tomas Holubec Petr Kacer Source Type: research