With the PMA approval, Berlin Heart’s Humanitarian Device Exemption categorization will be withdrawn and the ongoing regulations that dicated the use of the EXCOR® Pediatric at our clinical sites in North America up to now, including annual Institutional Review Board approval for use of the Humanitiarian Use Device designation will be removed.
“Obtaining PMA approval is very complex. We are proud of the results of our hard work and our ability to work effectively with the FDA on this unique project”, summarizes Bob Kroslowitz, CEO of the Berlin Heart Inc. To achieve a full market approval manufacturers need to demonstrate the safety and efficacy of their products. Thanks to the positive clinical experience with the EXCOR® Pediatric VAD, Berlin Heart could meet the high standards to obtain the PMA.
In 2007 EXCOR® Pediatric has received conditional approval for Investigational Device Exemption (IDE) purposes in the US market. After the successful multicenter IDE study the FDA has granted Berlin Heart Humanitarian Device Exemption (HDE) approval for the device in 2011. The HDE approval is now replaced by the Premarket Approval.
About Berlin Heart
Berlin Heart GmbH develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. With the EXCOR® Adult and the EXCOR® Pediatric, Berlin Heart is the only company in the world able to provide support to patients of every age and size, from infants to adults.
Berlin Heart’s systems provide left ventricular, right ventricular, or biventricular support (both sides); hospitals around the world use the system for short-, medium-, and long-term circulatory support, providing patients with a life-saving treatment option.
Users can also access round-the-clock medical and technical support.
The access to some or all shown products may be restricted by country-specific regulatory approvals. The use of EXCOR® VAD for adults, RVAD-support, Excor mobil and EXCOR® Active is not FDA-approved.