The FDA granted W.L. Gore & Associates the first U.S. clearance for using an endovascular graft to treat tears or ruptures in the aortic wall.
Gore’s Conformable TAG thoracic endoprosthesis was approved as a treatment for a transection or tear in the aortic wall, an injury typically the result of a car accident, crushing of the chest or a fall from a high place, according to an FDA release.
An aortic tear causes internal bleeding and is frequently fatal. The only other approved treatment option prior to Gore’s win was open surgical repair, according to agency.
The latest approval was made on the basis of data from 51 patients implanted with the Gore device to treat aortic tears caused by trauma.
All patients survived the implant procedure, and 4 died from causes unrelated to the device or implant procedure within the 30-day monitoring period. Gore plans to continue following the patients for 5 years, according to the release.
An endovascular graft is a fabric tube supported with a metal mesh frame, compressed into a catheter for delivery to the injury site.
Gore calls its device the only FDA cleared endoprosthesis specifically designed for young trauma patients. It is inserted via catheter through a small incision in the groin and threaded up the leg artery and into the chest, according to a press release.
The Conformable device first won FDA clearance in 2005 to treat aortic aneurysms to reduce the risk of rupture. The expanded approval applies to the latest device design, which features more flexible materials to conform to the curved areas where aortic tears commonly occur, according to the FDA release.
Torax’s Linx reflux management device wins unanimous FDA panel vote
The Linx reflux management system received a unanimous positive recommendation from the FDA’s Gastroenterology & Urology Devices Advisory Panel. Read more
Planmed Verity approved for EU
Planmed Verity, a mobile scanner for orthopedic imaging of the extremities, won CE mark is now available for sale in the EU and many other countries where the CE certificate permits sales. Read more
Ivera Medical wins 510(k) for disinfecting port protector
Ivera Medical Corp. received a new FDA 510(k) clearance for its Curos disinfecting port protector, adding to an existing clearance granted in 2008. Read more
Aerocrine wins market approval in South Korea and Taiwan
Aerocrine AB (PINK:ACNOF) won market approval in South Korea and in Taiwan for its Niox Mino asthma management systems. Read more
CardioComm wins first FDA clearance for OTC heart monitoring
CardioComm Solutions Inc. (CVE: EKG) landed FDA clearance for over-the-counter sales and marketing of its consumer-based, hand-held heart rhythm monitor known as the HeartCheck Pen Handheld ECG. Read more
Covidien provides update on voluntary sensor recall
There have been no reported injuries related to the recalled BIS bilateral sensors since to date. Covidien voluntarily recalled the devices in Nov. 2011 due to a problem that could potentially cause inaccurate calculations and presentation of EEG information. Read more
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.