Dec. 6 – Berlin Heart has begun enrollment in the prospective Investigational Device Exemption (IDE) study for its Excor Pediatric ventricular assist device (VAD), a mechanical cardiac support system for pediatric patients suffering from severe heart failure.
The multi-center IDE study seeks to evaluate the safety and efficacy of using the Excor Pediatric VAD to support pediatric patients, according to the Berlin-based Berlin Heart. The FDA granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients in May.
On Nov. 27, the first surgery was carried out at Arkansas Children’s Hospital in Little Rock, Ark. Berlin Heart said the Arkansas Children’s Hospital has treated 13 patients with Excor Pediatric, 12 of them under the compassionate use regulations.
The company also said its Excor Pediatric can be used as a bridge to transplantation for patients waiting for a donor heart, but has also been used as a bridge to recovery when a patient’s heart was able to recover and work on its own again.