Tendyne Holdings this month said its transcatheter mitral valve implant was implanted in the 1st U.S. patient as part of a global feasibility study.
The Tendyne device is designed to treat patients with symptomatic mitral regurgitation of degenerative or functional etiology – a condition that can lead to heart failure or death. The 1st 2 patients in the trial were implanted in Great Britain and Australia in December 2014, according to Tendyne founding investor Luxembourg-based Boulle Medtech Ltd.
"Enrolling the first patient in the U.S. into our global feasibility trial is an important milestone for Tendyne and the physician community," CEO Jeff Franco said in prepared remarks.
Tendyne raised a $25 million Series C round last year.
Tendyne, which is based in Minnesota, is competing with a number of other companies in the transcatheter mitral valve implant space.
Earlier this month, for example, the FDA granted an investigational device exemption to CardiAQ Valve Technologies for an early feasibility trial of its 2nd-generation transcatheter mitral valve implant. In March, Edwards Lifesciences (NYSE:EW) announced that a surgical team at London’s St. Thomas Hospital implanted the first 3 patients with its Fortis TMVI. Those patients were too sick to risk open heart surgery, Edwards said.
