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Berlin Heart GmbH

Berlin Heart touts pediatric heart device post-approval performance

July 2, 2020 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Pediatrics, Regulatory/Compliance, Structural Heart Tagged With: Berlin Heart GmbH, FDA

Heart pump beats current standard of care for kids awaiting transplant

August 9, 2012 By MassDevice staff Leave a Comment

Berlin Heart's Excor pediatric heart pump

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.

Filed Under: News Well, Pediatrics, Structural Heart Tagged With: Berlin Heart GmbH, Clinical Trials, Organ Transplant

Newly approved Berlin Heart helps patients waiting for a transplant

January 2, 2012 By MassDevice Leave a Comment

Berlin Heart transplant patient
On the Berlin Heart, Alina Siman, 4, has regained her energy which will make her a better transplant candidate when a new organ becomes available

By Lindsay Hoshaw

Filed Under: News Well, Pediatrics, Structural Heart Tagged With: Berlin Heart GmbH, Boston Children's Hospital

FDA approves Berlin Heart pediatric heart pump | Regulatory Roundup

December 19, 2011 By MassDevice staff Leave a Comment

Mela

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.

Filed Under: Food & Drug Administration (FDA), News Well, Pediatrics Tagged With: Berlin Heart GmbH, Bioptigen Inc., Organ Transplant, Regulatory Roundup, Verisante Technology

Arthrocare gets FDA nod for shoulder suture system | Regulatory Roundup

July 27, 2011 By MassDevice staff Leave a Comment

Arthrocare

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.

Filed Under: Diagnostics, News Well, Pediatrics, Structural Heart Tagged With: ArthroCare Corp., Berlin Heart GmbH, Caliper Life Sciences Inc., Shoulders

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