Edwards Lifesciences (EW) Recalls PASCAL's Guide Sheath
Zacks Investment Research | Nov 18, 2019 09:51PM ET
Edwards Lifesciences Corporation (NYSE:EW) 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.
Get The News You Want
Price Performance
The company’s shares, however, have gained 62% in the past year compared with the Zacks Investment Research
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.