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EW Wins FDA Approval for SAPIEN M3 as First Transseptal TMVR Therapy
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Key Takeaways
Edwards Lifesciences won FDA approval for SAPIEN M3, the first transseptal TMVR for mitral regurgitation.
EW's system targets patients unable to undergo surgery or edge-to-edge repair by using a transseptal approach.
One-year ENCIRCLE trial data showed 95.7% MR elimination, with strong safety and symptom improvement.
Edwards Lifesciences (EW - Free Report) announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making it the first minimally invasive, catheter-based treatment that uses a transseptal approach to treat mitral regurgitation.
The SAPIEN M3 system is designed for patients with moderate-to-severe mitral valve leakage symptoms who cannot undergo open-heart surgery or existing catheter-based edge-to-edge repair treatments. It is also approved for patients with severe mitral valve dysfunction linked to mitral annular calcification, including moderate-to-severe or severe mitral regurgitation (MR), severe mitral stenosis (MS) or a combination of both, when other treatment options are not suitable.
Per management, mitral regurgitation is a common heart valve condition and many patients suffer from severe symptoms that can be life-threatening and reduce their quality of life. The FDA approval of the SAPIEN M3 system is a major expansion of Edwards Lifesciences’ transcatheter portfolio that allows a minimally invasive mitral valve replacement solution that reduces MR and improves patient symptoms and overall well-being.
EW Stock Trend Following the News
Shares of Edwards Lifesciences have gained 0.1% since the announcement on Tuesday. Over the past six months, shares of the company have rallied 11.9% compared with the industry’s 3.5% growth and the S&P 500’s 15.6% rise.
Image Source: Zacks Investment Research
The FDA approval of SAPIEN M3 will enhance Edwards Lifesciences’ growth profile in the long run within the mitral valve market by opening a safe and effective treatment option for patients who were previously untreatable. For EW, the approval reinforces the company’s competitive position as a leader in minimally invasive heart therapies and expands its portfolio of heart valve technology.
EW currently has a market capitalization of $50.07 billion.
More on SAPIEN M3 System
The SAPIEN M3 transcatheter mitral valve replacement system is built on the company’s proven SAPIEN transcatheter platform. The TMVR procedure is performed through a percutaneous transseptal approach and involves a two-step process. First, a docking system is placed and then the replacement valve is delivered, replacing the damaged mitral valve. This minimally invasive design enables complete mitral valve replacement by inserting a thin, flexible tube called a sheath through the femoral vein in the leg without opening the chest, addressing a critical unmet need among high-risk patients.
Clinical validation results from the ENCIRCLE trial were shared at Transcatheter Cardiovascular Therapeutics (“TCT”) in October 2025 and published in The Lancet, a leading medical journal. One-year data demonstrated strong safety and effectiveness outcomes in 299 patients who had no other treatment options, achieving 95.7% rate of elimination of MR and significant improvements in symptoms. These results position the SAPIEN M3 system as a transformative option to treat mitral valve disease in the United States and drive the adoption by physicians.
The FDA approval of EW’s SAPIEN M3 TMVR system boosts the company’s 65-year-long contribution in developing innovative heart treatments and complements its FDA-approved transcatheter mitral and tricuspid therapies — PASCAL Precision mitral repair and EVOQUE tricuspid valve replacement systems. With the Conformité Européenne (CE) mark secured in early 2025 for the SAPIEN M3 system, EW is well-positioned to scale the SAPIEN M3 system, expanding its addressable market and reinforcing its long-term growth trajectory in structural heart innovation.
Industry Prospects Favoring the Heart Valve Device Market
Going by data provided by Precedence Research, the heart valve device market is valued at $14.89 billion in 2025 and is expected to witness a CAGR of 11.7% through 2034. Factors like increasing prevalence of vascular heart diseases, especially aortic stenosis and mitral regurgitation, development of minimally invasive transcatheter aortic valve replacement and repair procedures, AI-advanced diagnostic and screening modalities, and favorable reimbursement policies are driving the market’s growth.
Other News
Edwards Lifesciences is sponsoring the American Heart Association’s Heart Valve Initiative to improve care for 28 million people worldwide with heart valve disease. The program focuses on early diagnosis, clinician training, patient education, hospital certification, data collection and public awareness to reduce deaths and enhance treatment outcomes over the next five years.
The company presented seven-year data from the PARTNER 3 trials at TCT 2025, showing that its FDA-Approved SAPIEN 3 transcatheter aortic valve replacement therapy provides sustained patient benefits, excellent valve durability and superior clinical outcomes. The 10-year results from PARTNER 2 intermediate risk studies confirm Edwards Lifesciences’ leadership in delivering reliable, long-lasting heart-valve performance.
Veracyte, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%. You can see the complete list of today’s Zacks #1 Rankstocks here.
VCYT has an estimated earnings growth rate of 38.7% for 2025 compared with the industry’s 13.6% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.12%.
Artivion, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of 16 cents, which surpassed the Zacks Consensus Estimate by 14.3%. Revenues of $113.3 million beat the Zacks Consensus Estimate by 1.8%.
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EW Wins FDA Approval for SAPIEN M3 as First Transseptal TMVR Therapy
Key Takeaways
Edwards Lifesciences (EW - Free Report) announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making it the first minimally invasive, catheter-based treatment that uses a transseptal approach to treat mitral regurgitation.
The SAPIEN M3 system is designed for patients with moderate-to-severe mitral valve leakage symptoms who cannot undergo open-heart surgery or existing catheter-based edge-to-edge repair treatments. It is also approved for patients with severe mitral valve dysfunction linked to mitral annular calcification, including moderate-to-severe or severe mitral regurgitation (MR), severe mitral stenosis (MS) or a combination of both, when other treatment options are not suitable.
Per management, mitral regurgitation is a common heart valve condition and many patients suffer from severe symptoms that can be life-threatening and reduce their quality of life. The FDA approval of the SAPIEN M3 system is a major expansion of Edwards Lifesciences’ transcatheter portfolio that allows a minimally invasive mitral valve replacement solution that reduces MR and improves patient symptoms and overall well-being.
EW Stock Trend Following the News
Shares of Edwards Lifesciences have gained 0.1% since the announcement on Tuesday. Over the past six months, shares of the company have rallied 11.9% compared with the industry’s 3.5% growth and the S&P 500’s 15.6% rise.
Image Source: Zacks Investment Research
The FDA approval of SAPIEN M3 will enhance Edwards Lifesciences’ growth profile in the long run within the mitral valve market by opening a safe and effective treatment option for patients who were previously untreatable. For EW, the approval reinforces the company’s competitive position as a leader in minimally invasive heart therapies and expands its portfolio of heart valve technology.
EW currently has a market capitalization of $50.07 billion.
More on SAPIEN M3 System
The SAPIEN M3 transcatheter mitral valve replacement system is built on the company’s proven SAPIEN transcatheter platform. The TMVR procedure is performed through a percutaneous transseptal approach and involves a two-step process. First, a docking system is placed and then the replacement valve is delivered, replacing the damaged mitral valve. This minimally invasive design enables complete mitral valve replacement by inserting a thin, flexible tube called a sheath through the femoral vein in the leg without opening the chest, addressing a critical unmet need among high-risk patients.
Clinical validation results from the ENCIRCLE trial were shared at Transcatheter Cardiovascular Therapeutics (“TCT”) in October 2025 and published in The Lancet, a leading medical journal. One-year data demonstrated strong safety and effectiveness outcomes in 299 patients who had no other treatment options, achieving 95.7% rate of elimination of MR and significant improvements in symptoms. These results position the SAPIEN M3 system as a transformative option to treat mitral valve disease in the United States and drive the adoption by physicians.
The FDA approval of EW’s SAPIEN M3 TMVR system boosts the company’s 65-year-long contribution in developing innovative heart treatments and complements its FDA-approved transcatheter mitral and tricuspid therapies — PASCAL Precision mitral repair and EVOQUE tricuspid valve replacement systems. With the Conformité Européenne (CE) mark secured in early 2025 for the SAPIEN M3 system, EW is well-positioned to scale the SAPIEN M3 system, expanding its addressable market and reinforcing its long-term growth trajectory in structural heart innovation.
Industry Prospects Favoring the Heart Valve Device Market
Going by data provided by Precedence Research, the heart valve device market is valued at $14.89 billion in 2025 and is expected to witness a CAGR of 11.7% through 2034. Factors like increasing prevalence of vascular heart diseases, especially aortic stenosis and mitral regurgitation, development of minimally invasive transcatheter aortic valve replacement and repair procedures, AI-advanced diagnostic and screening modalities, and favorable reimbursement policies are driving the market’s growth.
Other News
Edwards Lifesciences is sponsoring the American Heart Association’s Heart Valve Initiative to improve care for 28 million people worldwide with heart valve disease. The program focuses on early diagnosis, clinician training, patient education, hospital certification, data collection and public awareness to reduce deaths and enhance treatment outcomes over the next five years.
The company presented seven-year data from the PARTNER 3 trials at TCT 2025, showing that its FDA-Approved SAPIEN 3 transcatheter aortic valve replacement therapy provides sustained patient benefits, excellent valve durability and superior clinical outcomes. The 10-year results from PARTNER 2 intermediate risk studies confirm Edwards Lifesciences’ leadership in delivering reliable, long-lasting heart-valve performance.
Edwards Lifesciences Corporation Price
Edwards Lifesciences Corporation price | Edwards Lifesciences Corporation Quote
EW’s Zacks Rank & Key Picks
Currently, EW has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Veracyte (VCYT - Free Report) , Artivion (AORT - Free Report) and EDAP TMS (EDAP - Free Report) .
Veracyte, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%. You can see the complete list of today’s Zacks #1 Rankstocks here.
VCYT has an estimated earnings growth rate of 38.7% for 2025 compared with the industry’s 13.6% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.12%.
Artivion, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of 16 cents, which surpassed the Zacks Consensus Estimate by 14.3%. Revenues of $113.3 million beat the Zacks Consensus Estimate by 1.8%.
AORT has an estimated earnings growth rate of 140% for 2025 compared with the industry’s 13.6% rise. The company delivered a negative average earnings surprise of 4.38% in the trailing four quarters.
EDAP, presently carrying a Zacks Rank #2, reported a third-quarter 2025 loss per share of 15 cents, 42.3% narrower than the Zacks Consensus Estimate. Revenues of $16.1 million topped the Zacks Consensus Estimate by 7.1%.
EDAP’s loss per share for 2025 is projected to widen 25.5%, while the industry’s earnings are expected to grow 13.6%. The company’s earnings beat estimates in the trailing four quarters, the average surprise being 19.36%.