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FDA OKs Edwards Lifesciences' Sapien 3 for Extended Use
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Shares of Edwards Lifesciences Corp. (EW - Free Report) edged up 2% to reach $114.95 yesterday, after the FDA granted an expanded indication for its leading products – Sapien 3 and Sapien XT transcatheter heart valves (THVs) – for treating severe, symptomatic aortic stenosis (AS) patients, who are at intermediate risk for open-heart surgery. Notably, these valves have been already in use for treating high-risk AS patients in the U.S. as well as international markets.
Interestingly, this news surfaced only a few days after the company’ s next-generation pericardial heart valve – the Intuity Elite System – got the marketing approval from the FDA. We believe these back to back news releases will keep Edwards in the MedTech headlines for sometime as of now, while at the same time enhancing the company’s presence in the global prosthetic heart valve market, which is estimated to reach a value worth $4.8 billion by 2020.
We are further optimistic to notice that this makes Edwards the first ever company in the U.S., which has had its THVs approved for TAVR therapy in intermediate risk patients.
Aortic Stenosis or AS, is a common yet serious medical condition, involving narrowing down of one’s aortic valve and its consequences include chest pain, heart failure, irregular heart rhythms, cardiac arrest or even death in the worst case scenario. Since medicine is not much effective, open-heart surgery has been traditionally the gold standard for replacing aortic valves in intermediate risk AS patients.
However, open-heart surgery bears a lot of risk by its own nature like a larger incision and greater recovery time. To avoid such complications, now-a-days transcatheter aortic valve replacement (TAVR) has been in vogue, as it is a minimally-invasive procedure that serves the purpose of valve replacement but is less risky when compared to open-heart surgery.
As per a recent press release by the FDA, in two separate clinical studies to evaluate the safety and efficacy of Edwards’ Sapien 3 and Sapien XT valves, both of these THVs have exhibited clinically significant improvements in intermediate risk patients when compared to those who received traditional open-heart surgery.
Our View
In last few decades, coronary artery disease has virtually engulfed a large portion of the global population, a very common side-effect for those suffering from AS; with the U.S. being no exception to that. In fact, heart disease is currently the leading cause of death in the nation. As per recent epidemiological studies, elder people aged 75 and older are more prone to fall victim of AS and thereby heart disease.
With rapid aging of the U.S. population growth observed in past few years and THV procedure adoption being still at a nascent stage in the nation, the U.S. market serves a great opportunity for THV producers like Edwards to leverage this situation and obtain maximum possible profits.
Interestingly, Edwards’ THV product line constitutes for more than 50% of the company’s total revenue and has been stimulating its growth for quite some time in the past. No doubt the extended FDA approval, now allowing physicians to treat one-third of AS patients referred for surgery with Sapien 3 and Sapien XT, will further fuel Edwards’ revenue growth from this product line.
Moreover, this approval will offer the company a competitive edge over the medical device giant Medtronic plc (MDT - Free Report) , whose CoreValve TAVR’s intermediate risk data is yet to hit the market.
While Edwards currently holds a Zacks Rank #2 (Buy), Medtronic carries a Zacks Rank #3 (Hold). Some favorably ranked medical stocks worth mentioning are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . Both these stocks sport a Zacks Rank #1 (Strong Buy).
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FDA OKs Edwards Lifesciences' Sapien 3 for Extended Use
Shares of Edwards Lifesciences Corp. (EW - Free Report) edged up 2% to reach $114.95 yesterday, after the FDA granted an expanded indication for its leading products – Sapien 3 and Sapien XT transcatheter heart valves (THVs) – for treating severe, symptomatic aortic stenosis (AS) patients, who are at intermediate risk for open-heart surgery. Notably, these valves have been already in use for treating high-risk AS patients in the U.S. as well as international markets.
Interestingly, this news surfaced only a few days after the company’ s next-generation pericardial heart valve – the Intuity Elite System – got the marketing approval from the FDA. We believe these back to back news releases will keep Edwards in the MedTech headlines for sometime as of now, while at the same time enhancing the company’s presence in the global prosthetic heart valve market, which is estimated to reach a value worth $4.8 billion by 2020.
We are further optimistic to notice that this makes Edwards the first ever company in the U.S., which has had its THVs approved for TAVR therapy in intermediate risk patients.
Aortic Stenosis or AS, is a common yet serious medical condition, involving narrowing down of one’s aortic valve and its consequences include chest pain, heart failure, irregular heart rhythms, cardiac arrest or even death in the worst case scenario. Since medicine is not much effective, open-heart surgery has been traditionally the gold standard for replacing aortic valves in intermediate risk AS patients.
However, open-heart surgery bears a lot of risk by its own nature like a larger incision and greater recovery time. To avoid such complications, now-a-days transcatheter aortic valve replacement (TAVR) has been in vogue, as it is a minimally-invasive procedure that serves the purpose of valve replacement but is less risky when compared to open-heart surgery.
As per a recent press release by the FDA, in two separate clinical studies to evaluate the safety and efficacy of Edwards’ Sapien 3 and Sapien XT valves, both of these THVs have exhibited clinically significant improvements in intermediate risk patients when compared to those who received traditional open-heart surgery.
Our View
In last few decades, coronary artery disease has virtually engulfed a large portion of the global population, a very common side-effect for those suffering from AS; with the U.S. being no exception to that. In fact, heart disease is currently the leading cause of death in the nation. As per recent epidemiological studies, elder people aged 75 and older are more prone to fall victim of AS and thereby heart disease.
With rapid aging of the U.S. population growth observed in past few years and THV procedure adoption being still at a nascent stage in the nation, the U.S. market serves a great opportunity for THV producers like Edwards to leverage this situation and obtain maximum possible profits.
Interestingly, Edwards’ THV product line constitutes for more than 50% of the company’s total revenue and has been stimulating its growth for quite some time in the past. No doubt the extended FDA approval, now allowing physicians to treat one-third of AS patients referred for surgery with Sapien 3 and Sapien XT, will further fuel Edwards’ revenue growth from this product line.
Moreover, this approval will offer the company a competitive edge over the medical device giant Medtronic plc (MDT - Free Report) , whose CoreValve TAVR’s intermediate risk data is yet to hit the market.
While Edwards currently holds a Zacks Rank #2 (Buy), Medtronic carries a Zacks Rank #3 (Hold). Some favorably ranked medical stocks worth mentioning are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . Both these stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>