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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
Analysts: Worst case unlikely in Medicare call on Boston Scientific’s Watchman anti-stroke device
The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts.
Boston Scientific shares took a hit earlier this month after the Centers for Medicare & Medicaid Services proposed to limit coverage for the Watchman device, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke. The FDA approved Watchman in March.
The federal health insurer proposed to limit coverage for Watchman to patients in approved clinical trials who can&#...
Source: Mass Device - November 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Stroke Source Type: news
Stroke Risk Reduction Outweighed Bleeding Risk Increase from Vitamin K Antagonists Treatment among Nonvalvular Atrial Fibrillation Patients with High Stroke risk and Low Bleeding Risk.
CONCLUSION: In NVAF patients at high risk for stroke and low risk for bleeding, our data confirm the effectiveness of anticoagulation for stroke prevention. The decrease in stroke risk of anticoagulation may outweigh the risk of major bleeding events, particularly among elderly patients. Potential risks of warfarin during initiation warrant attention, especially among patients who stop and start therapy repeatedly.
PMID: 28008771 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - December 25, 2016 Category: Research Tags: Curr Med Res Opin Source Type: research
Time to Cost-Effectiveness Following Stroke Reduction Strategies in AF Warfarin Versus NOACs Versus LAA Closure
ConclusionsBoth NOACs and LAAC with the Watchman device were cost-effective relative to warfarin, but LAAC was also found to be cost-effective and to offer better value relative to NOACs. The results of this analysis should be considered when formulating policy and practice guidelines for stroke prevention in AF.
Source: Journal of the American College of Cardiology - December 14, 2015 Category: Cardiology Source Type: research
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts.
Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke.
The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement Source Type: news
Cost effectiveness of left atrial appendage closure versus Warfarin for stroke risk reduction in non-valvular Atrial Fibrillation in CMS patients
Stroke is the most severe and debilitating consequence of atrial fibrillation (AF), with many patients ranking the resultant disability as worse than death. Warfarin, the established first-line therapy, is effective at reducing ischemic stroke, but is associated with increased bleeding risk and lower quality of life (QoL). Left atrial appendage closure (LAAC) with the Watchman Device has been found to be superior to warfarin at reducing risk of stroke in AF patients. This analysis sought to assess the cost effectiveness of LAAC versus warfarin for stroke prevention in non-valvular AF from the perspective of the US Centers ...
Source: Value in Health - May 1, 2015 Category: Global & Universal Authors: V. Reddy, R. Akehurst, S.L. Amorosi, S. Armstrong, S. Beard, C. Knight, C. Taggart, D. Holmes Source Type: research
National utilization patterns of warfarin use in older patients with atrial fibrillation: a population-based study of medicare part d beneficiaries.
CONCLUSIONS: Warfarin use rates vary by patient characteristics and region, with higher rates among residents of the Midwest and among patients seen by cardiologists and PCPs. Preventing stroke-related disability in AF requires implementation of evidence-based initiatives to increase warfarin use.
PMID: 23324508 [PubMed - in process]
Source: The Annals of Pharmacotherapy - January 1, 2013 Category: Drugs & Pharmacology Authors: Raji MA, Lowery M, Lin YL, Kuo YF, Baillargeon J, Goodwin JS Tags: Ann Pharmacother Source Type: research
Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
Long Term Outcomes and Anticoagulation in Mitral Valve Surgery - A Report from the Society of Thoracic Surgeons Database
CONCLUSIONS: Anticoagulation was used in less than half of mitral valve surgery. In MVrep patients, warfarin was associated with increased bleeding and was not protective against either stroke or mortality. In BMVR patients, warfarin was associated with a modest survival benefit, increased bleeding and equivalent stroke risk. NOAC was associated with increased adverse outcomes.PMID:37308066 | DOI:10.1016/j.athoracsur.2023.05.025
Source: The Annals of Thoracic Surgery - June 12, 2023 Category: Cardiovascular & Thoracic Surgery Authors: Thomas A Schwann Andrew M Vekstein Daniel T Engelman Dylan Thibault Joanna Chikwe Milo Engoren Mario Gaudino Sreekanth Vemulapalli Vinod Thourani Gorav Ailawadi Anthony Rousou Robert H Habib Source Type: research
Abstract 14: Clinical Characteristics and Treatment Patterns of Medicaid Patients with Atrial Fibrillation: Insights From the ORBIT-AF I Registry Session Title: Concurrent Session IIB: Oral Abstracts - Quality of Care
Conclusions: In a contemporary, community-based AF cohort, Medicaid patients had a greater comorbidity burden and higher stroke risk, yet were less likely to receive OAC compared with those with other forms of insurance.
Source: Circulation: Cardiovascular Quality and Outcomes - April 29, 2015 Category: Cardiology Authors: O'Brien, E. C., Kim, S., Thomas, L., Fonarow, G. C., Mahaffey, K. W., Kowey, P. R., Gersh, B. J., Burton, P. S., Piccini, J. P., Peterson, E. D. Tags: Session Title: Concurrent Session IIB: Oral Abstracts - Quality of Care Source Type: research
MassDevice.com +3 | The top 3 medtech stories for November 12, 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. SurgiQuest files for $75m IPO
SurgiQuest this week registered for an initial public offering estimated at $75 million.
Milford, Conn.-based SurgiQuest makes the AirSeal device for use in minimally invasive abdominal surgeries. AirSeal is designed to insufflate the rectum and provide continuous...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
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
