EUROPE- Medtechdive.com writes that Edwards Lifesciences issued a recall of the company’s Pascal transcatheter mitral valve repair system because of a possible defect in the device. According to reports, the device could have damage in the inner liner because of a manufacturing error. A defective device could result in an embolization in the liner.
The company instructed physicians to return the product to the manufacturer and not to implant the device in any patients. Edwards stressed that the recall is limited to the guides heath, not the entire product. The damage exists in one out of every 200 units.
Edwards started to sell the device in Europe as a competitor to Abbott’s MitraClip. The Pascal device is currently in trials in the United States.
The system failed to generate the earnings projected by the company. Executives at Edwards say that they are slowly introducing the product to the market to make sure that the procedure is successful.
The mitral device will become part of Edward’s line or structural heart devices along with the Sapien aortic valve replacement system.
The device is designed to treat patients who have secondary mitral valve disease. This condition can lead to the left chamber of the heart becoming enlarged and prevent the mitral leaflets from properly functioning.
The FDA approved the trial of the product in September. The product is being tested in the United States for patients with serious cases of tricuspid valve regurgitation.
Some of the devices were already implanted in patients. The recall does not indicate whether these individuals face any risks because of the devices.
Recalled implants present certain complications because patients would require surgery to have the device removed.
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