We could not be more pleased to have satisfied the FDA's requirements to provide US cardiac surgeons access to the Mitral Touch for their patients.
MORGAN HILL, Calif. (PRWEB) November 19, 2019
Mitre Medical is pleased to announce concurrent to the PCR-London Valves Conference that the FDA has determined Mitre Medical Corp. has provided sufficient data to support initiation of a human clinical study to evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency.
The Mitral Touch is an epicardial clip designed to reduce mitral regurgitation and provide subvalvular support of the left ventricle for functional mitral regurgitation (FMR) patients. Treating FMR on the outside of the beating heart is game changing for patients by eliminating the need to stop and slice open the patient’s heart. The increased risks of open-heart surgery include neurological events like stroke, supraventricular arrhythmias, and longer hospital stays.
John MacMahon, CEO of Mitre Medical, said, "We could not be more pleased to have satisfied the FDA's requirements to provide US cardiac surgeons access to the Mitral Touch for their patients. The minimally invasive delivery combined with the device’s familiar form factor provides an avenue for swift adoption.”
The initial patient experience was performed in Vilnius, Lithuania with five patients receiving the implant and followed for one year with durable reduction of mitral regurgitation and positive remodeling of the left ventricle.
“Patients have spoken. They want to feel better, they want something less invasive, and they want to live longer,” said Dr. Isaac George, Associate Professor of Medicine and Surgical Director of the Heart Valve Center at Columbia University Medical Center of New York. “There is tremendous potential to hit all three targets with the Mitral Touch device: I can see it being placed as a standalone procedure or during open-heart surgery to treat heart failure and functional mitral regurgitation. This study will be the starting point for an important trial to provide this evidence.”
The company expects its ENRAPT-US feasibility studies to begin first quarter, 2020.
About Mitre Medical Corp.
Mitre Medical Corp. is a medical device company with headquarters in Silicon Valley. The focus of the company is the development of innovative solutions to treat structural heart disease, including the Mitral Touch device. The Mitral Touch device is currently not approved by the FDA and is not CE marked.
About PCR-London Valves
PCR London Valves is an official course of the European Association of Percutaneous Cardiovascular Interventions. It is recognized as the world’s largest educational meeting approaching the question of patient care in the area of valvular heart disease. It specifically addresses percutaneous valve interventions and the rapidly expanding and innovative field of transcatheter therapies for valvular heart disease.