Berlin Heart’s Excor pediatric VAD
The FDA granted a humanitarian device exemption to Berlin Heart’s Excor pediatric ventricular assist device, after a unanimous recommendation from the federal watchdog agency’s Circulatory System Devices Advisory Panel.
The pediatric VAD is a mechanical cardiac assist device for critically ill pediatric patients suffering from severe heart failure. The system supports patients from newborns to teenagers, helping to keep them alive while they’re awaiting heart transplantation.
"This is a step forward – it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," Dr. Susan Cummins, chief pediatric medical officer in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart."
Berlin Heart’s pediatric VAD consists of one or two external air-driven blood pumps connected to the heart chambers and arteries by multiple tubes.
Heart failure in children is less common than in adults, but there are far fewer pediatric donor hearts available. The average wait time for an infant donor heart is 119 days, according to the FDA.
In a 48-patient, non-randomized multi-center trial, the Excor device was compared to extracorporeal membrane oxygenation, the standard treatment for pediatric patients waiting for transplant. In spite of a 29% stroke rate, 90% of children survived to transplant or were successfully weaned off of the VAD device.
In July, the FDA’s Circulatory System Devices Advisory Panel voted 16-0 that Berlin’s Excor system be granted humanitarian device exemption.
Cerevast wins CE Mark for stroke treatment
Redmond, Wash.-based Cerevast Therapeutics Inc. landed CE Mark clearance for its Clotbust ER ultrasound stroke treatment device used to treat ischemic stroke in the emergency room. Read more
VentriPoint passes audit, readies for sales
VentriPoint Diagnostics’ quality management system successfully passed its latest ISO 13485:2003 audit. The Seattle, Wash.-based company is now ready to ship the latest version of its VentriPoint Medical System to Europe in Canada. The company awaits U.S. approval in 2012. Read more
Verisante wins Australian approval
Skin cancer detection device maker Verisante Technology Inc. won approval by the Therapeutic Goods Administration of Australia to market its Verisante Aura skin cancer detection system in the land down under. 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.