This is a new product hoping soon to begin trials, and one would need to have a heart transplant to participate. According to the article, it would be approximately 2 years down the road before an FDA approval could be seen. So far it has only been tested on animals. BD
A Ballantyne company is preparing to start human testing of a device it hopes will dramatically reduce the need for biopsies after heart transplants.
“TransWorld Heart CorporationTM has developed a patented and patent-pending medical device based system to replace the current method of routine post-transplant heart biopsies. This system, the use of which is supported by leading cardiologists, will result in the elimination of frequent, sometimes painful, and costly biopsies while providing improved care and a higher quality of life. Based on patent- pending algorithms, our diagnostic approach to monitoring post-transplant heart health consists of an implanted monitoring device and proprietary software that will provide cardiologists with real-time heart health data”
TransWorld Heart Corp.’s device, known as the Soul Mate, is intended to provide doctors with daily data on heart-transplant patients without any need for expensive — and possible risky — biopsies.
A 10-person, pilot study at the Cleveland Clinic could start in the third quarter. It will cost about $2 million. Based on those results, the next step would be an expanded trial costing $10 million to $15 million.
Heart-transplant patients undergo frequent biopsies to check for rejection of the transplanted organ. Richardson says those tests present a limited view of the heart’s condition. All are taken from the right side of the heart. But two-thirds of the heart’s tissue is on the left side.