July 23, 2014 2:58 AM ET

Healthcare Equipment and Supplies

Company Overview of CardioKinetix, Inc.

Company Overview

CardioKinetix, Inc. develops transcatheter implantable devices for patients with left ventricular dilation after an anterior myocardial infarction. It offers Parachute, a ventricular partitioning membrane deployed within the compromised ventricle that partitions the damaged muscle, isolates the non-functional muscle segment from the functional segment, decreases the volume of the ventricle, and increases ejection fraction. CardioKinetix, Inc. was incorporated in 2002 and is headquartered in Menlo Park, California.

925 Hamilton Avenue

Menlo Park, CA 94025

United States

Founded in 2002

Phone:

650-364-7016

Fax:

650-364-7038

Key Executives for CardioKinetix, Inc.

Chief Executive Officer
Age: 48
Chief Financial Officer
Vice President of Research & Development
Controller
Age: 62
Vice President of Clinical
Compensation as of Fiscal Year 2014.

CardioKinetix, Inc. Key Developments

Cardiokinetix Provides Update on Parachute Iv, the Randomized Pivotal U.S. Trial of the Minimally Invasive Parachute Ventricular Partitioning Device for the Treatment of Heart Failure

CardioKinetix, Inc. announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute(TM) Ventricular Partitioning Device for the treatment of heart failure. PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 500 patients with ischemic heart failure at up to 65 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography. The first implant with the Parachute device was performed by David Mego, M.D., assistant medical director at Arkansas Heart Hospital in Little Rock, Arkansas, who treated a 39-year-old female with NYHA class III heart failure referred by Carl Leding, M.D., director of the Congestive Heart Failure Clinic at Arkansas Heart Hospital.

Cardiokinetix, Inc. Receives CE Mark Approval for Full Range of Sizes for Percutaneous Treatment for Heart Failure

CardioKinetix, Inc. announced it has received CE Mark approval for the full size matrix of its Parachute(TM) Ventricular Partitioning Device for Percutaneous Ventricular Restoration (PVR) therapy. The CE Mark approval for the full matrix of sizes of the Parachute implant is an important milestone; it will enable to provide this innovative treatment to a wide range of heart failure patients in the European Union. The Parachute device has been used in approximately 90 cases to date. Clinical results showing safety and meaningful and sustained low clinical events for patients with ischemic heart failure three years following treatment with the Parachute Ventricular Partitioning Device were presented at the 2012 European Society of Cardiology Conference in Munich in August. 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 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.

CardioKinetix, Inc. Announces Positive Three-Year Clinical Data for First-Of-Its-Kind Minimally Invasive Treatment for Heart Failure

CardioKinetix, Inc. announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure three years following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute(TM) Ventricular Partitioning Device. Data from thirty-one patients treated in the U.S. and Europe with the Parachute system demonstrate that the New York Heart Association (NYHA) class improvement observed at one and two years was maintained at three years post treatment (average NYHA class of 2.6 at baseline vs. 1.8 at three years, p<0.0001). The rate of hospitalization due to worsening heart failure was 29.7% at two years and 33.2% at three years, and the low rate of cardiac death of 6.5% at two years remained unchanged at three years, suggesting that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare favorably with current medical therapy in a similar high-risk patient population. Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

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