CardioKinetix Announces Positive Clinical Data Showing Consistent Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure
Meta-Analysis Presented at EuroPCR Substantiate Potential of Breakthrough Treatment for Heart Failure Patients; Largest Group Studied to Date
Paris and Menlo Park, Calif. — May 22, 2013 – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a meta-analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Six-month clinical results from 91 U.S. and European patients with ischemic heart failure were presented at the 2013 EuroPCR Conference in Paris by Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England.
“The results of this meta-analysis, which represents the largest group of patients studied to date, are consistent with previous positive findings and continue to substantiate the Parachute treatment as a viable technology – a very exciting prospect for physicians treating patients with heart failure,” said Dr. Thomas. “The Parachute promises to revolutionize the treatment for heart attack survivors whose hearts enlarge over time and subsequently suffer from heart failure symptoms, offering hope for a better qualify of life for many patients.”
Clinical data from 91 patients to reach six-month follow up demonstrates successful delivery and deployment of the Parachute implant, without the occurrence of major adverse cardiac events (MACE) related to the device, in 90 percent (82/91) of patients at six months following treatment. In addition, six months following treatment, 89 percent of patients demonstrated improved or maintained New York Heart Association (NYHA) functional class status. Specifically in the NYHA III subgroup, 27 percent improved two classes. The treatment also demonstrated a reduction in left ventricular volume, with a 20 percent reduction in end diastolic volume and a 23 percent reduction in end systolic volume (p<0.001).
“The results of this meta-analysis along with the recent completion of our post-market safety surveillance trial add to our excitement about the Parachute treatment, which we believe holds the potential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “Enthusiasm about the therapy continues to grow in the clinical community in Europe, where the therapy is available commercially, as well as in the United States, where the device is being studied in a landmark randomized pivotal trial.”
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.
About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]
About the Parachute® Ventricular Partitioning Device
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.
The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.
About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors, and H&Q Life Sciences Investors. For more information please visit www.cardiokinetix.com.