CardioKinetix Receives Expanded CE Approval for Parachute Percutaneous Left Ventricular Partitioning Device

CardioKinetix Receives Expanded CE Approval for Parachute Percutaneous Left Ventricular Partitioning Device

MENLO PARK, CA–(Marketwire – Jan 30, 2012) – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™), announced today that it has received CE Mark approval for two additional sizes of the Parachute™ implant.

After a heart attack, many heart failure 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™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. In clinical studies to date, the Parachute™ implant has shown to stop the progression of heart failure, reduce mortality, and improve quality of life.

“We are pleased to have received additional CE Mark approvals for the Parachute™ implant, and are enthusiastic about introducing the Parachute™ to treat heart failure patients in the European Union,” said Wes Johnson, President and CEO of CardioKinetix Inc. “These approvals will support our early commercialization efforts in select European markets through our PARACHUTE III clinical trial.”

CE Mark approval for the Parachute™ in Europe was supported by data from both the PARACHUTE clinical trial and PARACHUTE US feasibility trial. To support the development of post market clinical data, the Company is initiating the PARACHUTE III clinical trial. This trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.

About the Parachute™ Ventricular Partitioning Device

The Parachute™ is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The Parachute™ implant is comprised of a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial

PARACHUTE is a dual-arm (Parachute™ vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute™ implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About the PARACHUTE III Trial

PARACHUTE III is a dual-arm (Parachute™ vs. Optical Medical Therapy), open-label, multi-center registry, using CE Marked product, designed to evaluate the Parachute™ implant. The trial will enroll up to 100 patients with ischemic heart failure in up to 20 centers in Europe. The primary endpoint of the trial is procedural and device related Major Adverse Cardiac Events (MACE) through 60 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™). The Parachute™ intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix has developed a novel transcatheter implant called Parachute Ventricular Partitioning Device, which already received the CE mark and has now won approval for two additional sizes. The Parachute is a partitioning membrane deployed within the compromised ventricle that is intended to treat heart failure resulting from myocardial infarction.

parachute CardioKinetix Receives Expanded CE Approval for Parachute Percutaneous Left Ventricular Partitioning DeviceThe Parachute consists of a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The idea behind the device is that it partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

Early trials have shown the Parachute to decrease heart failure symptoms and increase exercise capacity and quality of life, with additional trials underway. If indeed proven effective, this could be an important addition to the interventional cardiologist’s toolbox.

Source : http://www.marketwire.com/press-release/cardiokinetix-receives-expanded-ce-mark-approval-worlds-first-percutaneous-left-ventricular-1612666.htm

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