PROTECT II Interim Results Demonstrate That Impella Is Not Superior to the Intra-Aortic Balloon Pump in Reducing Major Adverse Events in High Risk Patients Receiving Percutaneous Coronary Interventions

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Dec 09, 2010, 08:00 ET

MAHWAH, N.J., Dec. 9, 2010 /PRNewswire/ -- MAQUET Cardiovascular, the leading distributor of intra-aortic balloon pumps (IABP) worldwide, learned that the PROTECT II clinical trial, sponsored by Abiomed, that compared the safety and effectiveness of the Impella percutaneous ventricular assist device to intra-aortic balloon pumping in elective high-risk percutaneous coronary interventions (PCI) has been stopped. The Data Safety Monitoring Board determined, based on a review of the interim results, that Impella would likely not show a statistical difference in the rate of major adverse events compared to IABP at the completion of the trial.

The interim analysis of data from 305 patients, less than half of the 654 planned patients targeted for enrollment, showed no statistical difference in the rate of major adverse events, the primary endpoint of the trial, which included, but was not limited to, a difference in death, myocardial infarction and stroke between Impella and the IABP treatment groups. These results are consistent with an article published by Washington Hospital Center earlier this year, which questioned the clinical benefit of the PROTECT II study in this high-risk cohort of patients.

According to George W. Christy, MD, of Advocate Health System, Chicago, IL, "The trial did not meet the primary end-point and does not support use of a more expensive device with potentially higher complications over conventional and widely accepted IABP therapy."

"The trial speaks for itself – it did not meet the primary end-point," said Christian Keller, President and Chief Executive Officer of MAQUET Cardiovascular. "These results highlight what many cardiologists and hospital administrators have known for some time - IABP has been, and remains, the gold standard for delivering the critical cardiac support patients need in a way that also makes economic sense for the hospital."

About MAQUET IABP

MAQUET is the global leader in intra-aortic balloon pump (IABP) counterpulsation therapy. The company's continuing dedication to meeting the needs of interventionalists and cardiac surgeons through its ongoing program of research and development in IABP consoles, IAB catheters and related accessories have produced the most advanced technology offering known today. This, combined with the company's never ending commitment to clinical education, make MAQUET the gold standard for patients requiring mechanical cardiac assist. To learn more please visit MAQUET's website, http://ca.maquet.com/

About MAQUET Cardiovascular

MAQUET Cardiovascular is a leader in providing innovative products for cardiac surgery, vascular intervention and cardiac support to hospitals and clinics and the cardiac surgeons, interventional cardiologists, perfusionists and other healthcare professionals who care for patients with cardiovascular disease. MAQUET Cardiovascular is focused on providing clinicians with future-oriented technology that fits into their daily practice and improves the therapeutic management of patients. MAQUET Cardiovascular continues to invest in the development of innovative technologies and solutions that advance clinical practice, improve patient outcomes and enhance quality of life.

MAQUET Cardiovascular was formed in 2003 when MAQUET, the world's leading medical technology company, combined its existing Cardiopulmonary business with Jostra's equipment and consumables for open heart surgery and Siemens Life Support Systems, which the publicly-listed Swedish GETINGE Group acquired in 2003. In 2008, MAQUET added the Cardiac Surgery and Vascular Interventions businesses acquired by GETINGE from Boston Scientific and Guidant. In 2009, it added the cardiac assist businesses that GETINGE acquired from Datascope. MAQUET Cardiovascular provides healthcare professionals with products in four business units: Cardiopulmonary (perfusion products), Cardiac Surgery (clampless beating heart and endoscopic vessel harvesting), Vascular Interventions (grafts for vascular surgery), and Cardiac Assist (intra-aortic balloon counterpulsation therapy).

About The MAQUET Group

The MAQUET Group is the global market leader for Medical Systems, focusing on the Operating Room (OR), Cath Lab, Intensive Care Unit (ICU) and Patient Transport. The integrated products of MAQUET are specially designed to deliver optimal clinical treatment and therapeutic applications within acute care hospitals. MAQUET provides innovative medical solutions from three Divisions:

Cardiovascular with products for cardiac assist (intra-aortic balloon counterpulsation therapy), coronary artery bypass surgery, complex aortic surgery reconstruction, peripheral interventions and extracorporeal circulation
Critical Care for intensive care ventilators and anesthesia machines
Surgical Workplaces for OR tables, lights and ceiling service units, flexible room design for OR, Cath Lab and ICU as well as digital OR integration

MAQUET is a subsidiary of the publicly-listed Swedish GETINGE GROUP, a company with around $3 billion in revenue (2009 fiscal year) and 12,100 employees worldwide. In 2009 MAQUET itself generated revenue of around $1.5 billion. The company now has more than 5,000 employees in 36 international sales and service organizations, as well as a network of more than 250 distributors. Twelve manufacturing sites are located in six countries.

www.maquet.com

www.getingegroup.com

MAQUET – The Gold Standard.

SOURCE MAQUET Cardiovascular