CE Mark For Full Size Range of CardioKinetix Parachute™ Ventricular Partitioning Devices

In short

We’ve covered CardioKinetix Inc., and its funky Parachute™ Ventricular Partitioning Device before, most recently when it announced a new “real world” post marketing study in Germany, here. Now the company has announced it has received CE Mark approval for the full size matrix of the device, opening up Percutaneous Ventricular Restoration (PVR) therapy to a wider patient cohort.

Background

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.

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.

New data from patients treated with the Parachute device will be presented this week at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference taking place October 22 – 26 in Miami, Fla.

Physician comments

“We have been very encouraged with the results of the Parachute cases at our hospital. Now that the Parachute is available in eight sizes, it addresses a significant unmet need in ischemic heart failure, with the potential to improve the lives of thousands patients with this devastating condition,” said Drs. Jozef Bartunek, Associate Director, and Marc Vanderheyden, Associate Director, from the Cardiovascular Center Aalst, OLV Ziekenhuis, Belgium

Company comments

“The CE Mark approval for the full matrix of sizes of the Parachute implant is an important milestone; it will enable us to provide this innovative treatment to a wide range of heart failure patients in the European Union. We are finalizing our plans for our initial commercial launch in Europe in 2013,” said Maria Sainz, president and CEO of CardioKinetix.

Regulatory status

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.

Source: CardioKinetix, Inc.