Berlin Heart announced today that it completed the post-approval surveillance process for its Excor pediatric ventricular assist device (VAD). Post-approval surveillance is a requirement of the post-market approval that Berlin Heart’s Excor received from the FDA in June 2017. The company’s final report to the FDA confirmed positive results in pediatric heart failure patients treated […]
Berlin Heart GmbH
Heart pump beats current standard of care for kids awaiting transplant
Children with heart failure survived longer while awaiting a heart transplant when they received therapy with Berlin Heart’s Excor pediatric ventricular assist device than when treated with the current standard of care, according to a new study.
The Excor PAD device was not without risks, but survival rates for children on the device were "significantly higher" than those in the control group, according to the study’s authors.
Newly approved Berlin Heart helps patients waiting for a transplant
FDA approves Berlin Heart pediatric heart pump | Regulatory Roundup
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.
Arthrocare gets FDA nod for shoulder suture system | Regulatory Roundup
ArthroCare Corp. (NSDQ:ATRC) landed FDA clearance for its SpeedFix suture system for repairing tears in the shoulder joint, a common injury.
The sutures tout independent bone locking, suture tensioning and suture locking to fasten tissue to bone using double-loaded proprietary MagnumWire sutures.
The company won FDA clearance for their SpeedFix anchor system in November 2010.
