The FDA plans to launch new guidelines on the clinical testing of drug-coated stents in response to questions about risks of blood clots and other complications. The new rules will not affect stents that are already commercially available. They are expected to cover the size of trials and say how long patients should stay on the anti-clotting drug Plavix after getting a stent.
Boston Scientific Corp. said it has agreed to sell its fluid-management and venous-access units to private-equity firm Avista Capital Partners for $425 million as part of its plan to divest nonstrategic assets. The deal is expected to close in the first quarter.
FDA officials, doctors and device makers at a conference in Boston on Thursday discussed the issues surrounding the voluntary reports and laboratory tests that examine ICD leads for potential fractures.
Xcorporeal's battery-powered artificial kidney was able to administer dialysis to eight kidney-failure patients for four to eight hours during a pilot trial, researchers said. The wearable device shows promise for patients with end-stage kidney failure since it has the potential to deliver frequent dialysis for a long period of time.
An FDA panel has voted in favor of the approval of Hologic's Adiana, a device used in sterilizing women to prevent pregnancies, on the condition that further studies will be conducted to evaluate the long-term risks and effectiveness of the device. Adiana, which has a 98.9% one-year efficacy rate, uses a catheter to implant soft material smaller than a grain of rice into the fallopian tube with the aid of radio signals.