HighLife successfully initiates its clinical feasibility phase

HighLife SAS announced today the successful treatment of 5 consecutive patients in its early feasibility clinical phase. The first three cases were carried out in Kiev (Ukraine) in the adult clinic of the Ukrainian Children’s Cardiac Center (UCCC), directed by Ilya Yemets MD, PhD as part of a feasibility clinical study. The following two cases were performed by Corrado Tamburino MD, PhD and his team at Ferrarotto Hospital in Catania (Italy) under compassionate use.

The HighLife technology relies on the initial placement of a ring component around the native mitral leaflets in a reversible manner. Once this first component’s position is confirmed, the bioprosthesis can be delivered within minutes through the ring and in position inside the native annulus.

All procedures were carried out as planned, and were successful according to MVARC criteria. The various periods of follow up ranged up to four months and included unchanged valve function over time.

“The HighLife approach is truly unique through the interaction of its two components enabling treatment of patients otherwise not eligible for conventional surgery.” said Professor Yemets, cardiac surgeon, “After these three successful cases, we are looking forward to treating further patients.”

“In both cases we performed, the patients remained stable throughout the procedure. The presence of the ring component acting as a big fluoroscopic marker facilitated remarkably the valve delivery.” said Professor Tamburino, “We are looking forward to further participating in the clinical evaluation of this technology.”

The clinical study in Kiev is a ten patient, non-randomized, single center, prospective clinical study approved by the Ukrainian Ministry of Health. It is targeting treatment of patients with severe mitral regurgitation who have been evaluated by a multidisciplinary Heart Team as inoperable or at high risk for surgical repair/replacement.

The Italian Ministry of Health and the local Ethics Committee approved the treatment of the two patients in Catania under compassionate use due to their severe co morbidities and their ineligibility to any other surgical or beating heart treatment of their mitral insufficiency.

The clinical cases were done with the assistance of Ruediger Lange MD, PhD, head of cardiac surgery in the German Hear Center in Munich (Germany) and Nicolo Piazza MD, PhD, FRCPC, FESC interventional cardiologist at McGill University Health Center in Montreal (Canada), whose contributions and guidance have been instrumental in the development of the technology.

“We are very happy about this initial series of clinical cases, which shows the clinical proof of concept of our innovative technology.Together with these outstanding clinical centers in Kiev and Catania, we look forward to extending the clinical evaluation of our technology and developing a unique and less invasive solution for patients suffering from mitral regurgitation,” said Georg Börtlein, Founder and Chief Executive Officer of HighLife.