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Edwards Lifesciences (EW) Wins FDA Nod for the EVOQUE System
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Edwards Lifesciences (EW - Free Report) recently secured the FDA’s approval for the EVOQUE tricuspid valve replacement system, a first-of-its-kind transcatheter therapy for the treatment of tricuspid regurgitation (TR). The system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
The latest development will strongly boost the company’s Transcatheter Mitral and Tricuspid Therapies (“TMTT”) product group. Earlier, in October 2023, the EVOQUE system received the CE Mark regulatory approval, making it the world's first transcatheter valve replacement therapy to be approved to treat TR.
News in Detail
The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s proven bovine pericardial tissue. The EVOQUE valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.
Image Source: Zacks Investment Research
Successful six-month results from TRISCEND II — the randomized controlled pivotal trial studying the EVOQUE system — were presented at the 35th Transcatheter Cardiovascular Therapeutics (“TCT”), the annual scientific symposium of the Cardiovascular Research Foundation. The findings reported favorable safety and effectiveness outcomes, demonstrating superiority to OMT alone and meeting all primary endpoints. Key findings in the trial included significant reduction or elimination of TR and significant and sustained quality of life improvement while demonstrating a favorable balance between risk and benefit.
Alongside the six-month cohort, 318 of the total 392 randomized patients completed a one-year visit, and the results showed favorable trends in the device group compared to the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, KCCQ, NYHA and 6MWD. Edwards expects to present the full cohort of 392 TRISCEND II pivotal trial patients at TCT 2024.
More on the News
Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease. The company’s leadership expressed gratitude for the strong collaboration with clinicians worldwide who contributed to the EVOQUE system, which is now available through the FDA’s Breakthrough Pathway to provide a treatment option to many patients in the United States suffering from tricuspid valve disease.
Industry Prospects
Per a research report, the global tricuspid valve repair market was valued at $638.1 million in 2022 and is expected to witness a CAGR of 5.9% by 2030.
Progress in the TMTT Business
The company achieved several important milestones during the third quarter of 2023, highlighting its commitment to the unmet needs of mitral and tricuspid patients. Sales of TMTT products increased 65%, driven by the accelerated adoption of the differentiated PASCAL precision platform, the activation of more centers across the United States and Europe and key TEER (Transcatheter edge-to-edge repair) pulmonary hypertension (ph) procedural growth.
Favorable clinical outcomes continue to exhibit the impressive performance of PASCAL Precision and the comprehensive high-touch model. Moreover, the company completed enrollment for the ENCIRCLE pivotal trial for SAPIEN M3 mitral valve replacement, slowly advancing toward offering an important valve replacement option beyond TEER to serve even more patients suffering from mitral valve disease.
Price Performance
In the past six months, EW shares have risen 7.8% compared with the industry’s growth of 1.5%.
Zacks Rank and Key Picks
Edwards Lifesciences currently carries a Zacks Rank #3 (Hold).
Haemonetics’ stock has fallen 8.7% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in fiscal 2024 and increased from $4.15 to $4.19 in fiscal 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have increased from $1.91 to $1.97 in the past 30 days. Shares of the company have dropped 33.1% in the past year compared with the industry’s fall of 0.6%.
PODD’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 30.7% in the past year compared with the industry’s 5.7% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.
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Edwards Lifesciences (EW) Wins FDA Nod for the EVOQUE System
Edwards Lifesciences (EW - Free Report) recently secured the FDA’s approval for the EVOQUE tricuspid valve replacement system, a first-of-its-kind transcatheter therapy for the treatment of tricuspid regurgitation (TR). The system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
The latest development will strongly boost the company’s Transcatheter Mitral and Tricuspid Therapies (“TMTT”) product group. Earlier, in October 2023, the EVOQUE system received the CE Mark regulatory approval, making it the world's first transcatheter valve replacement therapy to be approved to treat TR.
News in Detail
The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s proven bovine pericardial tissue. The EVOQUE valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.
Image Source: Zacks Investment Research
Successful six-month results from TRISCEND II — the randomized controlled pivotal trial studying the EVOQUE system — were presented at the 35th Transcatheter Cardiovascular Therapeutics (“TCT”), the annual scientific symposium of the Cardiovascular Research Foundation. The findings reported favorable safety and effectiveness outcomes, demonstrating superiority to OMT alone and meeting all primary endpoints. Key findings in the trial included significant reduction or elimination of TR and significant and sustained quality of life improvement while demonstrating a favorable balance between risk and benefit.
Alongside the six-month cohort, 318 of the total 392 randomized patients completed a one-year visit, and the results showed favorable trends in the device group compared to the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, KCCQ, NYHA and 6MWD. Edwards expects to present the full cohort of 392 TRISCEND II pivotal trial patients at TCT 2024.
More on the News
Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease. The company’s leadership expressed gratitude for the strong collaboration with clinicians worldwide who contributed to the EVOQUE system, which is now available through the FDA’s Breakthrough Pathway to provide a treatment option to many patients in the United States suffering from tricuspid valve disease.
Industry Prospects
Per a research report, the global tricuspid valve repair market was valued at $638.1 million in 2022 and is expected to witness a CAGR of 5.9% by 2030.
Progress in the TMTT Business
The company achieved several important milestones during the third quarter of 2023, highlighting its commitment to the unmet needs of mitral and tricuspid patients. Sales of TMTT products increased 65%, driven by the accelerated adoption of the differentiated PASCAL precision platform, the activation of more centers across the United States and Europe and key TEER (Transcatheter edge-to-edge repair) pulmonary hypertension (ph) procedural growth.
Favorable clinical outcomes continue to exhibit the impressive performance of PASCAL Precision and the comprehensive high-touch model. Moreover, the company completed enrollment for the ENCIRCLE pivotal trial for SAPIEN M3 mitral valve replacement, slowly advancing toward offering an important valve replacement option beyond TEER to serve even more patients suffering from mitral valve disease.
Price Performance
In the past six months, EW shares have risen 7.8% compared with the industry’s growth of 1.5%.
Zacks Rank and Key Picks
Edwards Lifesciences currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , Insulet (PODD - Free Report) and DaVita (DVA - Free Report) . Each of them presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Haemonetics’ stock has fallen 8.7% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in fiscal 2024 and increased from $4.15 to $4.19 in fiscal 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have increased from $1.91 to $1.97 in the past 30 days. Shares of the company have dropped 33.1% in the past year compared with the industry’s fall of 0.6%.
PODD’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 30.7% in the past year compared with the industry’s 5.7% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.