FDA grants Breakthrough Device designation to CathHELIX®, HVR Cardio’s catheter-based mitral valve repair device

Espoo, Finland, 25 September 2019 – HVR Cardio, the cardiovascular device company developing new transformative solutions for mitral valve repair, today announces that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), has granted Breakthrough Device designation for its lead product, CathHELIX®.

CathHELIX® is an investigational transcatheter mitral valve repair system that is designed to treat symptomatic severe mitral regurgitation, or “leaky valve”, the most common heart valve disorder, which affects 2% of the population and 10% of individuals aged over 75. Mitral regurgitation severely limits physical activity and quality of life and, if left untreated, leads to heart failure and death.

CathHELIX®, which is based on HVR Cardio’s innovative helix ring technology, is designed to be routinely used by interventional cardiologists. It is intended to provide a new treatment option for patients at high risk for mitral valve surgery, which is less invasive and lower risk but retains the efficacy of surgical repair and keeps future treatment options open. It has the potential to both significantly improve the quality of life and help avoid unnecessary loss of life for patients suffering from this debilitating disease.

The FDA grants ‘Breakthrough Device’ designation to devices that may prevent or treat a life-threatening or irreversibly debilitating disease or condition. Under the Breakthrough Devices program, the FDA will provide its support to advance CathHELIX® from development to launch. As part of this, the FDA is committed to be closely involved in the design of efficient and flexible clinical trials, as well as the collection of pre- and post-market data.

Olli Keränen, CEO and Founder of HVR Cardio, commented:
“We are pleased that the FDA has decided to grant Breakthrough Device designation to CathHELIX®. It is great recognition of the clinical benefit our technology can offer in providing a new, less invasive treatment option for patients suffering from mitral valve disease, while retaining the efficacy of surgical repair. We look forward to working with the FDA and progressing the development of our device.”

For more information, please contact:
Oli Keränen, CEO of HVR Cardio
Tel: +358 50 356 7090
Email: ok@medtentia.com

Instinctif Partners (media relations)
Melanie Toyne-Sewell / Katie Duffell
Tel: +44 20 7457 2013
Email: medtentia@instinctif.com

About HVR Cardio International Ltd Oy
HVR Cardio International Ltd Oy is an innovative cardiovascular device company developing transformative solutions for mitral valve repair based on its groundbreaking helix technology platform.

Mitral regurgitation, or leaking valve, is the most common heart valve disorder in people aged over 60. Mitral regurgitation, if left untreated, often leads to heart failure and death. HVR Cardio is developing both transcatheter and surgical solutions for repairing the leaking mitral valve. HVR Cardio’s IP is protected by over 50 patent families.

HVR Cardio’s transcatheter mitral valve repair solution, CathHELIX®, targets the largest business opportunity in structural heart and has received Breakthrough Device Designation from the FDA. The advantages of CathHELIX® include, among others, the ability to utilise an annuloplasty ring without any external fixation in the mitral valve repair. CathHELIX® also leaves future treatment options open.

HVR Cardio’s first-in-class surgical mitral valve repair solution, MAR, has already demonstrated strong safety and efficacy results in 11 mitral regurgitation patients. Based on the clinical and preclinical results to date, MAR may provide significant benefits in terms of operation time, consistency, and left ventricle reverse remodeling (recovery of the heart).