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Boston Scientific (BSX) WATCHMAN FLX Pro Gets FDA Approval
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Boston Scientific, Inc. (BSX - Free Report) recently announced receiving the FDA approval for the latest-generation WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device. The latest device is intended to advance the procedural performance and safety of the WATCHMAN technology. The device now features a polymer coating, visualization markers and a broader size matrix to treat a wider range of patients.
The recent development will fortify Boston Scientific’s Cardiology segment.
More on WATCHMAN FLX Pro Device
The WATCHMAN FLX Pro device is based on the WATCHMAN FLXTM LAACdevice's demonstrated safety and operational performance. The most recent WATCHMAN FLX Pro device has been improved with a coating meant to decrease device-related thrombus and promote quicker, more regulated healing and endothelization of the device surface. Additionally, newly-added visualization indicators are meant to improve device placement for the best LAA sealing.
The WATCHMAN FLX Pro device will be assessed in the post-market HEAL-LAA research, which will start in the coming weeks and track the progress of about 1,000 patients with NVAF who had the device implanted at 60 sites in the United States.
Significance of the New Device
Per Boston Scientific’s management, the newest LAAC technology, intended to improve post-procedure healing, increase the accuracy of WATCHMAN FLX Pro implants, and broaden the size range of treated appendages, is now available to clinicians in the United States. The WATCHMAN FLX technology has been improved, speeding up implant procedures and letting doctors give their patients the best possible care.
Image Source: Zacks Investment Research
The fully rounded design that enables medical professionals to enter and move around the left atrial appendage securely is one of the primary features of the WATCHMAN FLX Pro device that has been carried over from the original WATCHMAN FLX. The company believes that the WATCHMAN device's progress also holds out hope for a future with lower thrombosis risk, which could allow patients to have a more straightforward post-implant medication regimen.
Industry Prospects
Per a report by Grand View Research, the global left atrial appendage closure devices market size was estimated at $986.35 million in 2021 and is expected to witness a CAGR of 20.5% by 2030. The industry is witnessing strong demand, owing to the changes in lifestyle, better access to healthcare services and the rising geriatric population prone to CVDs. Furthermore, electrophysiology procedures represent a significant opportunity for the market.
Recent Developments
Boston Scientific has recently completed enrollment for the WATCHMAN FLX Pro CT pilot study, a single study design using multiple imaging modalities to assess post-procedural healing in the next generation of WATCHMAN FLX Pro. The company expects continued momentum within the WATCHMAN franchise supported by the anticipated approval of the WATCHMAN FLX Pro and the steerable sheath called Trusteer by the end of 2023.
In the second quarter of 2023, Boston Scientific noted that WATCHMAN’s organic sales grew 27% year over year. The U.S. demand remained strong and international growth was led by China and Japan.
Price Performance
In the past year, BSX shares have gained 29.9% against the industry’s fall of 2.9%.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Haemonetics’ stock has risen 19.9% in the past year. Earnings estimates for Haemonetics have increased from $3.56 to $3.74 in 2023 and $3.96 to $4.07 in 2024 in the past 30 days. It currently sports a Zacks Rank #1.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Quanterix’s 2023 loss per share have narrowed from $1.19 to 97 cents in the past 30 days. Shares of the company have increased 167.5% in the past year against the industry’s decline of 1.7%. It currently carries a Zacks Rank #2 (Buy).
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for SiBone’s2023 loss have narrowed from $1.42 to $1.27 per share in the past 30 days. Shares of the company have increased 31% in the past year compared with the industry’s rise of 1.9%. It currently carries a Zacks Rank #2.
SIBN’s earnings beat estimates in all the trailing four quarters, the average surprise being 20.37%. In the last reported quarter, SiBone delivered an earnings surprise of 26.83%.
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Boston Scientific (BSX) WATCHMAN FLX Pro Gets FDA Approval
Boston Scientific, Inc. (BSX - Free Report) recently announced receiving the FDA approval for the latest-generation WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device. The latest device is intended to advance the procedural performance and safety of the WATCHMAN technology. The device now features a polymer coating, visualization markers and a broader size matrix to treat a wider range of patients.
The recent development will fortify Boston Scientific’s Cardiology segment.
More on WATCHMAN FLX Pro Device
The WATCHMAN FLX Pro device is based on the WATCHMAN FLXTM LAACdevice's demonstrated safety and operational performance. The most recent WATCHMAN FLX Pro device has been improved with a coating meant to decrease device-related thrombus and promote quicker, more regulated healing and endothelization of the device surface. Additionally, newly-added visualization indicators are meant to improve device placement for the best LAA sealing.
The WATCHMAN FLX Pro device will be assessed in the post-market HEAL-LAA research, which will start in the coming weeks and track the progress of about 1,000 patients with NVAF who had the device implanted at 60 sites in the United States.
Significance of the New Device
Per Boston Scientific’s management, the newest LAAC technology, intended to improve post-procedure healing, increase the accuracy of WATCHMAN FLX Pro implants, and broaden the size range of treated appendages, is now available to clinicians in the United States. The WATCHMAN FLX technology has been improved, speeding up implant procedures and letting doctors give their patients the best possible care.
The fully rounded design that enables medical professionals to enter and move around the left atrial appendage securely is one of the primary features of the WATCHMAN FLX Pro device that has been carried over from the original WATCHMAN FLX. The company believes that the WATCHMAN device's progress also holds out hope for a future with lower thrombosis risk, which could allow patients to have a more straightforward post-implant medication regimen.
Industry Prospects
Per a report by Grand View Research, the global left atrial appendage closure devices market size was estimated at $986.35 million in 2021 and is expected to witness a CAGR of 20.5% by 2030. The industry is witnessing strong demand, owing to the changes in lifestyle, better access to healthcare services and the rising geriatric population prone to CVDs. Furthermore, electrophysiology procedures represent a significant opportunity for the market.
Recent Developments
Boston Scientific has recently completed enrollment for the WATCHMAN FLX Pro CT pilot study, a single study design using multiple imaging modalities to assess post-procedural healing in the next generation of WATCHMAN FLX Pro. The company expects continued momentum within the WATCHMAN franchise supported by the anticipated approval of the WATCHMAN FLX Pro and the steerable sheath called Trusteer by the end of 2023.
In the second quarter of 2023, Boston Scientific noted that WATCHMAN’s organic sales grew 27% year over year. The U.S. demand remained strong and international growth was led by China and Japan.
Price Performance
In the past year, BSX shares have gained 29.9% against the industry’s fall of 2.9%.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , Quanterix (QTRX - Free Report) and SiBone (SIBN - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Haemonetics’ stock has risen 19.9% in the past year. Earnings estimates for Haemonetics have increased from $3.56 to $3.74 in 2023 and $3.96 to $4.07 in 2024 in the past 30 days. It currently sports a Zacks Rank #1.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Quanterix’s 2023 loss per share have narrowed from $1.19 to 97 cents in the past 30 days. Shares of the company have increased 167.5% in the past year against the industry’s decline of 1.7%. It currently carries a Zacks Rank #2 (Buy).
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for SiBone’s2023 loss have narrowed from $1.42 to $1.27 per share in the past 30 days. Shares of the company have increased 31% in the past year compared with the industry’s rise of 1.9%. It currently carries a Zacks Rank #2.
SIBN’s earnings beat estimates in all the trailing four quarters, the average surprise being 20.37%. In the last reported quarter, SiBone delivered an earnings surprise of 26.83%.