MAQUET Cardiovascular Receives FDA 510(k) Clearance And CE Mark Approval For Its New SENSATION PLUS® 7.5Fr 40cc Intra-Aortic Balloon Catheter
WAYNE, N.J., Oct. 29, 2012 /PRNewswire/ — MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new SENSATION PLUS(®) 7.5Fr. 40cc intra-aortic balloon (IAB) catheter. This new larger-volume, fiber-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy “at the speed of light” to smaller patients – those who are 5’0″ to 5’4″ tall (152-162 cm). It will be available for sale in the United States and in the EU in October.
“Over the last 12 months, MAQUET has launched two new families of IAB catheters, as well as a new balloon pump, CARDIOSAVE(®) – all of which are designed to revolutionize counterpulsation therapy, from both an efficacy and safety perspective,” said Christian Keller, President and CEO of MAQUET Cardiovascular. “As a global leader in hemodynamic support, we are dedicated to developing and marketing new and innovative products that continuously improve the therapy needs of hemodynamically compromised patients thereby improving patient outcomes.”
Since October 2011, MAQUET has added new sizes to its higher efficacy IAB product lines to improve the delivery of hemodynamic support to the most critically ill patients. In addition to the SENSATION PLUS 8 Fr. 50cc catheter, MAQUET has launched the SENSATION PLUS 7.5Fr 40cc IAB for patients 5’0″ to 5’4″ (152-162 cm). Earlier this year, the company introduced its new MEGA(® )IAB catheters, a family of larger volume catheters (30cc, 40cc and 50cc) that allow clinicians to provide a significant increase in hemodynamic support to patients at any height. In 2012, MAQUET also launched CARDIOSAVE, the company’s new fiber-optic intra-aortic balloon pump designed with a large state-of-the-art touchscreen display and is smaller, lighter and quieter than any pump the company has ever offered.
Features and Benefits of SENSATION PLUS IAB Catheters
SENSATION PLUS IAB catheters are a technological first in improved hemodynamic support, offering all of the benefits of MAQUET’s easy-to-use IAB fiber-optic technology with the increased clinical effectiveness that larger volume IABs offer. Larger volume balloons displace more blood in the aorta during diastole, resulting in improved diastolic augmentation and systolic unloading.
The SENSATION PLUS IAB catheters automatically calibrate in the patient after insertion and automatically recalibrate in vivo every two hours or sooner if patient or environmental conditions change. The result is faster time to therapy, ongoing consistency and accuracy of the arterial blood pressure waveform, and improved ease-of-use.
Like MAQUET’s MEGA IAB catheters, the SENSATION PLUS IAB catheters come with two STATLOCK(®) IAB Stabilization Devices*, which allow the catheter to be secured to the patient’s leg without sutures. This is more comfortable for the patient and eliminates the risk of suture needle sticks for the clinician when initiating counterpulsation support.
About IAB Counterpulsation Therapy
IAB counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the IAB is inserted into the patient’s aorta and counterpulsates with the heart, it augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand. For more than 40 years, it has been the standard of care for critically ill patients who require hemodynamic support, with more than 1 million patients treated.
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 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 2011, Maquet generated nearly 1.4 billion Euro which is more than half of the Group’s annual revenue of 2.4 billion Euros. The Getinge Group has 13,000 employees worldwide, including around 6,000 MAQUET employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives. For more information please visit www.maquet.com and www.getingegroup.com.
*STATLOCK is a registered trademark of C.R. Bard Inc.
SOURCE MAQUET Medical Systems USA