Maquet Cardiovascular LLC Announces FDA 510(k) Clearance and CE Mark for the CARDIOSAVE™ Intra-Aortic Balloon Pump
11/11/2011 6:49:19 AM
MAHWAH, N.J., Nov. 10, 2011 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced U.S. Food & Drug Administration (FDA) 510(k) clearance and CE mark today at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco for its new CARDIOSAVE intra-aortic balloon pump (IABP). CARDIOSAVE is expected to be commercially available in the United States in January 2012.
The new CARDIOSAVE IABP incorporates a large state-of-the-art touchscreen display and is dramatically smaller, lighter and quieter than any pump the company has ever offered. The pump is being offered in two configurations: CARDIOSAVE Hybrid for routine in-hospital use and CARDIOSAVE Rescue for use in ambulances and aircraft.
"We are excited to introduce CARDIOSAVE at this year's TCT since this is the first new balloon pump launched by MAQUET since its acquisition of Datascope Corp.," said Christian Keller, President and Chief Executive Officer of MAQUET Cardiovascular. "CARDIOSAVE represents a major advancement in IABP versatility and functionality while leveraging the performance and intuitiveness of the Datascope pumps our customers have trusted for over 40 years."
Keller continues, "We will continue to grow our strong product portfolio and revenues through innovation of current products and through successful acquisitions, like the 2009 Datascope and the recently completed Atrium Medical acquisitions, to ensure we continue to provide the best possible solutions for physicians and patients."
Intra-aortic balloon counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the intra-aortic balloon is inserted into the patient's aorta, it counterpulsates with the heart and augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand.
"The advanced user interface and improved patient interconnects make it very intuitive and easy to use," said Raoul Quintero, President, MAQUET U.S. Sales and Service Organization. "Additionally, the ability to "hot swap" batteries allows virtually unlimited battery run time capability and allows patients who are being supported by the pump in one facility to be easily transported to another without any interruption in support regardless of the length of transport."
For more information about MAQUET Cardiovascular, please visit http://ca.maquet.com.
INFORMATION ABOUT MAQUET
As a trusted partner for hospitals and clinicians since 1838, MAQUET is a global leader in medical systems that advance surgical interventions, cardiovascular procedures and critical care. MAQUET develops and designs innovative products and therapeutic applications for the operating room, hybrid OR/cath lab, intensive care unit and patient transport within acute care hospitals, improving outcomes and quality of life for patients.
Cardiovascular specialties include intra-aortic balloon counterpulsation (IABC) therapy for cardiac assist, coronary artery bypass surgery, aortic and peripheral vascular surgery, and extracorporeal circulation.
The Critical Care portfolio includes market-leading intensive care ventilators and anesthesia machines.
MAQUET also equips Surgical Workplaces with critical infrastructure such as flexible room design for OR and ICU, OR tables, lights and ceiling supply units, and OR integration for image data management.
MAQUET is a subsidiary of the publicly listed Swedish Getinge Group. In 2010, MAQUET generated nearly half of the Group's annual revenue of 2.3 billion Euros. The Getinge Group has more than 12,000 employees worldwide, including about 5,000 MAQUET employees in 36 international sales and service organizations, as well as a network of more than 250 sales representatives. For more information please visit www.maquet.com and www.getingegroup.com.
MAQUET The Gold Standard.
SOURCE MAQUET Cardiovascular