Studies support anti-stroke PFO closure devices from Abbott, Gore

Sykes and Clark; licensee BioMed Central Ltd. A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients. Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurrent ischemic stroke compared with anti-stroke medications. “It is a major new treatment option for some people,” Dr. Jeffrey Saver, lead author of Abbott’s Respect study, said in prepared remarks. “Using the device is going to have to be a considered clinical decision between the doctor and the patient about who’s the right person to get it. “There are patients for whom it is clearly the best thing to do,” Saver said. “There are patients for whom it should probably be avoided, and patients for whom it’s still a gray zone.” Respect Intent-to-treat data from Respect showed that recurrent ischemic stroke occurred in 18 patients in the Amplatzer group and 28 patients in the medical-therapy group, or 0.58% and 1.07 %, respectively. Cryptogenic stroke occurred in 10 patients in the PFO closure group and...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Surgical Abbott Structural heart W.L. Gore & Associates Source Type: news