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Boston Scientific's (BSX) WATCHMAN FLX to Offer DAPT in the US

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Boston Scientific Corporation (BSX - Free Report) recently gained FDA approval to expand the current-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device’s instructions for use labeling. Per management, the revised labeling equips physicians with greater flexibility to exercise their clinical judgment based on individual patient characteristics to select the most suitable post-procedural antithrombotic medication regimen.

The revised labeling will include a 45-day dual anti-platelet therapy (“DAPT”) option, which will serve as an alternative to the 45-day oral anticoagulation (“OAC”) plus aspirin for post-procedural treatment of non-valvular atrial fibrillation (NVAF) patients. It is worth noting that the labeling for the WATCHMAN technology in Europe has offered the option of either OAC or DAPT post-procedural drug regimen since 2017.

The updated labeling was backed by clinical findings submitted to the FDA, including the analyses of around 8,300 patients from the Left Atrial Appendage Occlusion Registry (LAAO Registry) within the American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry (NCDR). The purpose of the submission was to demonstrate the safety and effectiveness of DAPT as a post-procedural antithrombotic regimen in NVAF patients who might be looking for an alternative to OAC.

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Other favorable clinical findings backing the WATCHMAN FLX device comprise the results of an analysis of more than 17,000 patients from the NCDR-LAAO Registry. The results revealed no significant difference in rates of major adverse events at 45 days after implant, regardless of whether patients were discharged from the hospital on DAPT, a direct OAC and aspirin, or warfarin and aspirin.

In addition, the latest data from the SURPASS analysis of over 16,000 patients from the NCDR-LAAO Registry demonstrated low rates of adverse events and peri-device leak over 45 days following implant. Meanwhile, the investigator-led SEAL-FLX study showed that the WATCHMAN FLX technology had a significantly higher rate of complete occlusion of the left atrial appendage at eight weeks compared with the Amulet device (72.6% vs. 30.5%), based on contrast-enhanced cardiac computed tomography imaging.

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The CHAMPION-AF and OPTION clinical trials are two ongoing studies that are assessing the use of the WATCHMAN FLX device for broader patient populations with NVAF.

Industry Prospects

Per a report by Coherent Market Insights, the global antiplatelet drugs market is expected to see a CAGR of 7.8% during 2022-2030. Factors such as the growing prevalence of cardiovascular diseases, a surge in the geriatric population and a sedentary lifestyle can be attributable to market growth.

Given the market prospects, the FDA-approved revised labeling for the WATCHMAN FLX device seems opportune.

Notable Developments

In Aug 2022, Boston Scientific announced the acquisition of Obsidio, Inc. This privately-held company is a renowned developer of the FDA-authorized Gel Embolic Material (GEM) technology, which is used to embolize blood vessels in the peripheral vasculature. The buyout expands Boston Scientific’s interventional oncology and embolization portfolio with a differentiated solution for physicians and patients suffering from hemorrhages, cancer and other debilitating conditions.

In June 2022, the company entered into a definitive agreement with Synergy Innovation Co., Ltd, to acquire the latter’s majority stake (roughly 64%) of M.I.Tech Co., Ltd ("M.I.Tech"). M.I.Tech is a publicly traded Korean company that developed the HANAROSTENT technology— a family of conformable, non-vascular, self-expanding metal stents. The purchase price stated in the agreement is KRW 14,500 per share, subject to fulfillment of closing adjustments.

Share Price Performance

The stock has outperformed its industry in the past year. It has lost 10.5% against the industry’s 51.8% decline.

Zacks Rank & Key Picks

Boston Scientific currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , ShockWave Medical, Inc. (SWAV - Free Report) and McKesson Corporation (MCK - Free Report) .

AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has lost 9.2% against the industry’s 38.7% fall.

ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.

ShockWave Medical has outperformed its industry in the past year. SWAV has gained 17% against the industry’s 34% fall in the past year.

McKesson has an estimated long-term growth rate of 9.9%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2 (Buy).

McKesson has outperformed its industry in the past year. MCK has gained 75.6% against the industry’s 15.5% fall.

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