Myocor, Inc. announced that its percutaneous iCoapsys™ device was successfully implanted by Dr. Wes Pedersen, an interventional cardiologist with the Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, on May 7, 2008.
iCoapsys is one of two Myocor devices designed to treat patients with mitral valve insufficiency caused by heart failure and coronary artery disease (CAD). It is the subject of the Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) study, which was conditionally approved for investigational use by the U.S. Food and Drug Administration on November 3, 2007.
According to Dr. Pedersen, “The iCoapsys device offers patients — especially those patients with mitral regurgitation who are not good candidates for major heart surgeries — an innovative, less invasive option designed to treat a debilitating condition. This device and the percutaneous implant procedure, delivered without open-heart surgery, offer the hope of a significant improvement in the patient’s quality of life.”
The CoapsysÃ‚® and iCoapsys devices represent two delivery options for a single reshaping therapy designed to address mitral valve regurgitation. Both devices consist of two pads that are positioned on the outside of the heart and connected by a flexible cord. They are designed to reshape the geometry of the heart and to realign the leaflets of the mitral valve to restore valve integrity and function. The original, surgically implanted Coapsys device is currently being evaluated in the RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve) clinical trial.
Myocor CEO Jim Hickey said, “This first human implant of our iCoapsys device is a significant milestone and a great step forward for the patients who will have the option of a less invasive therapy.”
According the Dr. Pederson, “We are seeing a surge of interest in percutaneous valve procedures. As we demonstrate the safety and efficacy of percutaneously implanting the iCoapsys device, we expect greater interest on the part of primary care physicians and cardiologists. There are significant numbers of patients with functional mitral regurgitation who could eventually benefit from this therapy.”
Dr. Pedersen has significant clinical research experience in percutaneous valve procedures and has been a practicing cardiologist at the Minneapolis Heart Institute since 1991.
About the technology:
The CoapsysÃ‚® and iCoapsys™ devices are designed to deliver the only complete, less invasive reshaping therapy for Functional Mitral Regurgitation and left ventricle dysfunction. These products are currently for investigational use only.
About the company:
Myocor is a Minneapolis-based, clinical-trial stage medical device company. Its primary focus is on developing pioneering therapies that restore heart geometry and function. By addressing both ventricular and valvular issues, Myocor’s therapies offer a complete reshaping solution for the millions of people worldwide who suffer from debilitating functional mitral regurgitation.
About the Minneapolis Heart Institute Foundation:
Through groundbreaking clinical research and innovative education programs, the Minneapolis Heart Institute Foundation is creating a world without heart disease. Using more effective diagnostic techniques and treatment protocols, the Foundation is improving individuals’ health and reducing the mortality rate associated with cardiovascular disease.