HVR Cardio International Ltd Oy today announced that the surgeons at Helsinki University Hospital led by Prof Werkkala have successfully continued to recruit patients for the official second phase of the clinical approval study evaluating the safety and efficacy of the “HVR Cardio Helix Ring in Adults Undergoing Mitral Valve Repair Surgery”.
After review and recommendation by Data Safety Monitoring Board and ethical authorities the competent authority has approved the study continuation. The second phase of the clinical study will commence as a multi-center study in several European countries in 2013.
The preliminary results after more than 85 patient months show consistent and sustained hemodynamic valve performance without adverse events and support the unique advantages of the helix ring technology. All the safety and performance study objectives have been achieved so far.
The HVR Cardio Helix Ring leverages the company’s proprietary helix-technology platform featuring a safe and intelligent mitral valve repair and replacement technique simplifying and shortening surgery. HVR Cardio’s helix based products may benefit patients by enabling small-incision surgical approaches and reduced operative times, leading to potentially reduced morbidity and faster recovery also for patients undergoing complex cardiac procedures. The HVR Cardio helix-technology provides also promising opportunities for catheter-based mitral valve interventions.
About HVR Cardio International Ltd Oy
HVR Cardio International Ltd Oy is a clinical-stage medical technology company developing innovative products for mitral valve repair and replacement based on the company’s proprietary helix technology. The company, located in Helsinki, Finland is backed by leading Nordic venture capital funds.
Additional company information can be found at www.medtentia.com.
Olli Keränen, CEO +358 50 3567090
Prof Hans-Reinhard Zerkowski, COB +41 79 2767139