Drs. Ryan Krone & Karen Havenstrite discussed COR Innovations’ solution to preventing congestive heart failure (CHF), following myocardial infarction (i.e. heart attack) with a minimally-invasive, device-based technology, at http://www.bio2devicegroup.org .
Heart failure affects 5.8 million people in the U.S. alone and is responsible for nearly 1 million hospitalizations each year. The cost to healthcare industry in 2010 was a staggering $25B and is projected to triple to $75B by 2030. There is only 50% survival rate, 5 years after the diagnosis. Heart failure is a progressive disease. Myocardial infarction, commonly known as a heart attack, results from the interruption of blood supply to a part of the heart, causing heart cells to die. This is most commonly due to occlusion or blockage of a coronary artery following the rupture of plaque clogging the walls of an artery. A vicious circle of ischemia, decreased cardiac output and reinfarction makes it largely incurable and progressive disease. First line of treatment regimen begins with prescription medications to help heart function and may include Beta Blockers, Diuretics, and ACE Inhibitors. But when the heart is greatly damaged and needs additional support, there are device based interventions including pacemakers and implantable Defibrillators. And finally there are surgical options that include heart valve repair, coronary artery bypass, implantable heart pump and finally heart transplant. Paracor was a company that offered passive restraint device to offload the weakened heart muscle. Though the device was less invasive compared to sternotomy, it was an invasive surgery, with added complications of severe immune response requiring the need for immunosuppressive medications with severe side effects and was therefore offered only to end stage patients.
COR Innovations has a novel passive restraint solution that encapsulates the heart in hydrogel which is highly biocompatible, eliminating the severe immune response. Further, it is significantly less invasive since the liquid hydrogel can be administered through the catheter and it can polymerize in-situ. This is FDA approved material, adheres to the heart, and is adjustable. However, there are challenges that the team is currently working to resolve. While the material offers great advantages, is perfectly suitable for the application, is biocompatible, and it disintegrates and leeches out in about a year, the bigger challenges are with respect to delivery. Once mixed, the material polymerizes in 30 seconds and the challenge is to ensure that the time is sufficient to encapsulate the heart. Also the ideal level of thickness versus the strength of the polymer for optimal restraint has to be found. The unique method of delivery makes it possible to deliver non-invasively but poses these challenges. Discussing the regulatory pathway, Havenstrite shared that they would follow the PMA pathway, given that this is a new material with a new indication. The topic generated great interest and was followed by Q&A.