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Edwards Lifesciences (EW) Gets FDA Nod for MITRIS RESILIA Valve
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Edwards Lifesciences Corporation (EW - Free Report) recently gained FDA approval for its MITRIS RESILIA valve-- a tissue valve replacement intended explicitly for the heart's mitral position. The MITRIS RESILIA valve is based on the reliable Carpentier-Edwards PERIMOUNT platform.
The addition of MITRIS RESILIA valve completes the portfolio of surgical heart valve innovations incorporating the advanced RESILIA tissue, which includes an aortic valve, an aortic valved conduit and presently a mitral valve.
The latest FDA approval is likely to bolster the company’s Surgical Structural Heart business. The MITRIS RESILIA valve has also been approved by regulatory bodies in Japan, Canada and other nations.
More on the MITRIS RESILIA Valve
The MITRIS RESILIA valve offers improved RESILIA tissue with an anti-calcification technology which enables devices to be stored under dry packaging conditions for ease of use. The RESILIA tissue is bovine pericardial tissue studied in two robust pre-market clinical trials, including the COMMENCE trial and the EU Feasibility trial. It is worth noting that the RESILIA tissue serves as the platform for Edwards Lifesciences’ new class of valves.
The MITRIS RESILIA valve resembles the asymmetric shape of the native mitral valve. It has a low-profile frame that helps prevent stent posts from obstructing the left ventricular outflow tract. It is also visible under fluoroscopy to allow for potential transcatheter interventions for patients. The MITRIS RESILIA valve combines tissue with integrity-preservation technology to help enhance the valve’s longevity.
Image Source: Zacks Investment Research
Per management, the MITRIS RESILIA valve has been designed to function similarly to the native mitral valve, handling the highest pressure in the heart and providing sustained hemodynamic performance, instilling surgeons and patients' confidence in this novel therapy option.
Industry Prospects
Per a report by MarketWatch, the transcatheter mitral valve repair and replacement market is set to witness a CAGR of 30% during 2021-2026. Factors such as a surge in the geriatric population, growing mitral valve disorders, technological advancements and the introduction of new mitral valves are fuelling market growth.
Given the market prospects, the latest FDA approval for the MITRIS RESILIA valve comes at an opportune time.
Developments in Surgical Structural Heart Business
During the fourth quarter 2021, Edwards Lifesciences’ Surgical Structural Heart sales rose 8.4% from the year-ago quarter on a reported basis and 9.3% on an underlying basis. The upside in the Surgical Structural Heart business was led by the growing uptake of the INSPIRIS RESILIA aortic surgical valve, the KONECT RESILIA aortic tissue valve conduit and the MITRIS RESILIA valve worldwide. The company saw increased prioritization of life-saving surgical therapies over elective procedures in the quarter amid worsening hospital staffing shortages.
Share Price Performance
The stock has outperformed its industry over the past year. It has rallied 40.5% compared to the industry’s growth of 5.2%.
Zacks Rank and Key Picks
Currently, Edwards Lifesciences carries a Zacks Rank #2 (Buy).
A few better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Henry Schein, Inc. (HSIC - Free Report) and McKesson Corporation (MCK - Free Report) .
AMN Healthcare has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, 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 gained 41.3% versus the 53.5% industry decline.
Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.5%. It currently has a Zacks Rank #2.
Henry Schein has outperformed the industry over the past year. HSIC has gained 27% compared with the industry’s 11% rise over the past year.
McKesson has a long-term earnings growth rate of 11.8%. McKesson’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 20.6%, on average. It presently carries a Zacks Rank #2.
McKesson has outperformed the industry over the past year. MCK has gained 58.1% in the said period compared with 10.9% growth of the industry.
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Edwards Lifesciences (EW) Gets FDA Nod for MITRIS RESILIA Valve
Edwards Lifesciences Corporation (EW - Free Report) recently gained FDA approval for its MITRIS RESILIA valve-- a tissue valve replacement intended explicitly for the heart's mitral position. The MITRIS RESILIA valve is based on the reliable Carpentier-Edwards PERIMOUNT platform.
The addition of MITRIS RESILIA valve completes the portfolio of surgical heart valve innovations incorporating the advanced RESILIA tissue, which includes an aortic valve, an aortic valved conduit and presently a mitral valve.
The latest FDA approval is likely to bolster the company’s Surgical Structural Heart business. The MITRIS RESILIA valve has also been approved by regulatory bodies in Japan, Canada and other nations.
More on the MITRIS RESILIA Valve
The MITRIS RESILIA valve offers improved RESILIA tissue with an anti-calcification technology which enables devices to be stored under dry packaging conditions for ease of use. The RESILIA tissue is bovine pericardial tissue studied in two robust pre-market clinical trials, including the COMMENCE trial and the EU Feasibility trial. It is worth noting that the RESILIA tissue serves as the platform for Edwards Lifesciences’ new class of valves.
The MITRIS RESILIA valve resembles the asymmetric shape of the native mitral valve. It has a low-profile frame that helps prevent stent posts from obstructing the left ventricular outflow tract. It is also visible under fluoroscopy to allow for potential transcatheter interventions for patients. The MITRIS RESILIA valve combines tissue with integrity-preservation technology to help enhance the valve’s longevity.
Image Source: Zacks Investment Research
Per management, the MITRIS RESILIA valve has been designed to function similarly to the native mitral valve, handling the highest pressure in the heart and providing sustained hemodynamic performance, instilling surgeons and patients' confidence in this novel therapy option.
Industry Prospects
Per a report by MarketWatch, the transcatheter mitral valve repair and replacement market is set to witness a CAGR of 30% during 2021-2026. Factors such as a surge in the geriatric population, growing mitral valve disorders, technological advancements and the introduction of new mitral valves are fuelling market growth.
Given the market prospects, the latest FDA approval for the MITRIS RESILIA valve comes at an opportune time.
Developments in Surgical Structural Heart Business
During the fourth quarter 2021, Edwards Lifesciences’ Surgical Structural Heart sales rose 8.4% from the year-ago quarter on a reported basis and 9.3% on an underlying basis. The upside in the Surgical Structural Heart business was led by the growing uptake of the INSPIRIS RESILIA aortic surgical valve, the KONECT RESILIA aortic tissue valve conduit and the MITRIS RESILIA valve worldwide. The company saw increased prioritization of life-saving surgical therapies over elective procedures in the quarter amid worsening hospital staffing shortages.
Share Price Performance
The stock has outperformed its industry over the past year. It has rallied 40.5% compared to the industry’s growth of 5.2%.
Zacks Rank and Key Picks
Currently, Edwards Lifesciences carries a Zacks Rank #2 (Buy).
A few better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Henry Schein, Inc. (HSIC - Free Report) and McKesson Corporation (MCK - Free Report) .
AMN Healthcare has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, 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 gained 41.3% versus the 53.5% industry decline.
Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.5%. It currently has a Zacks Rank #2.
Henry Schein has outperformed the industry over the past year. HSIC has gained 27% compared with the industry’s 11% rise over the past year.
McKesson has a long-term earnings growth rate of 11.8%. McKesson’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 20.6%, on average. It presently carries a Zacks Rank #2.
McKesson has outperformed the industry over the past year. MCK has gained 58.1% in the said period compared with 10.9% growth of the industry.