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Edwards Lifesciences Corporation (EW - Free Report) is in the process of recalling a guide sheath used with its PASCAL transcatheter mitral valve repair system sold in Europe because of a possible damage to the device's inner liner due to a manufacturing issue, as per an urgent field safety notice issued by it voluntarily. The urgent field safety notice has been shared among the international regulators.
Shares of the company dipped 1.3% to close at $242.38 on Nov 18, 2019 following the news.
For investor’s note, all lots of model numbers 10000GS and 10000GSCE are subject to the recall.
Few Words on PASCAL
The PASCAL transcatheter valve repair system belongs to the company’s Transcatheter Mitral and Tricuspid Therapies (“TMTT”) portfolio. It received the CE Mark for the treatment of patients with mitral regurgitation in February 2019.
The PASCAL system is an important offering from Edwards Lifesciences as it provides a differentiated and minimally-invasive therapy to treat the patients with mitral regurgitation. So far, the PASCAL’s performance has been impressive in Europe. The company was also in the process of enrolling its CLASP IID U.S. pivotal trial to study PASCAL in primary or degenerative mitral valve disease.
Reason Behind the Recall
Per the field safety notice, a potential damage to the inner liner of the PASCAL guide sheath has been identified. However, the possibility of occurrence of the damage is approximately 0.5%, or 1 out of 200 units.
The guide sheath used along with the PASCAL has been recalled on the suspicions of the occurrence of an embolization (blockage or obstruction of the blood vessels or organs) in a segment of the liner material if the device is used. However, no adverse outcome or patient injuries have been reported as yet. However, information on whether the patients already implanted with the guide sheaths have also been affected or not, is currently not available.
Further, per Edwards Lifesciences, the recall will be applicable only to the guide sheath and not the whole PASCAL transcatheter valve repair system. The company has issued an advisory to the patients to not use the current guide sheaths and return them on a priority basis for replacement.
For investor’s note, the company has strongly advised the customers to review the safety notice.
Price Performance
The company’s shares, however, have gained 62% in the past year compared with the industry’s growth of 12.6%.
Zacks Rank & Other Key Picks
Currently, Edwards Lifesciences carries a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks from the broader medical space are Haemonetics Corporation (HAE - Free Report) , NuVasive, Inc and ResMed Inc (RMD - Free Report) .
NuVasive’s long-term earnings growth rate is estimated at 10.9%. The company currently has a Zacks Rank #2 (Buy).
ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently carries a Zacks Rank #2.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Edwards Lifesciences (EW) Recalls PASCAL's Guide Sheath
Edwards Lifesciences Corporation (EW - Free Report) is in the process of recalling a guide sheath used with its PASCAL transcatheter mitral valve repair system sold in Europe because of a possible damage to the device's inner liner due to a manufacturing issue, as per an urgent field safety notice issued by it voluntarily. The urgent field safety notice has been shared among the international regulators.
Shares of the company dipped 1.3% to close at $242.38 on Nov 18, 2019 following the news.
For investor’s note, all lots of model numbers 10000GS and 10000GSCE are subject to the recall.
Few Words on PASCAL
The PASCAL transcatheter valve repair system belongs to the company’s Transcatheter Mitral and Tricuspid Therapies (“TMTT”) portfolio. It received the CE Mark for the treatment of patients with mitral regurgitation in February 2019.
The PASCAL system is an important offering from Edwards Lifesciences as it provides a differentiated and minimally-invasive therapy to treat the patients with mitral regurgitation. So far, the PASCAL’s performance has been impressive in Europe. The company was also in the process of enrolling its CLASP IID U.S. pivotal trial to study PASCAL in primary or degenerative mitral valve disease.
Reason Behind the Recall
Per the field safety notice, a potential damage to the inner liner of the PASCAL guide sheath has been identified. However, the possibility of occurrence of the damage is approximately 0.5%, or 1 out of 200 units.
The guide sheath used along with the PASCAL has been recalled on the suspicions of the occurrence of an embolization (blockage or obstruction of the blood vessels or organs) in a segment of the liner material if the device is used. However, no adverse outcome or patient injuries have been reported as yet. However, information on whether the patients already implanted with the guide sheaths have also been affected or not, is currently not available.
Further, per Edwards Lifesciences, the recall will be applicable only to the guide sheath and not the whole PASCAL transcatheter valve repair system. The company has issued an advisory to the patients to not use the current guide sheaths and return them on a priority basis for replacement.
For investor’s note, the company has strongly advised the customers to review the safety notice.
Price Performance
The company’s shares, however, have gained 62% in the past year compared with the industry’s growth of 12.6%.
Zacks Rank & Other Key Picks
Currently, Edwards Lifesciences carries a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks from the broader medical space are Haemonetics Corporation (HAE - Free Report) , NuVasive, Inc and ResMed Inc (RMD - Free Report) .
Haemonetics, currently sporting a Zacks Rank #1, has a projected long-term earnings growth rate of 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
NuVasive’s long-term earnings growth rate is estimated at 10.9%. The company currently has a Zacks Rank #2 (Buy).
ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently carries a Zacks Rank #2.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>