Clinical and Industry News January 2008
- Posted on: 6/19/08
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Abiomed Receives FDA Approval for the Combination iPulse™ Circulatory Support System
Abiomed, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for U.S. commercial distribution of the company’s combination iPulse™ Circulatory Support System. The iPulse drives Abiomed and other manufacturer’s intra-aortic balloons (IAB), Abiomed’s BVS® 5000 and AB5000® Ventricular Assist Devices (VAD), as well as new products Abiomed may offer in the future. These products are designed to treat patients suffering from acute heart failure by offering various levels of cardiac support, whether minimal, moderate, or full bi-ventricular, to potentially recover the patient’s native heart. The iPulse is the first console with the capability to provide either VAD or IAB support in the catheterization lab and surgery suite.
There are an estimated 160,000 IABs used globally each year with approximately 110,000 annual U.S. procedures. Over 1,000 open heart hospitals, which include approximately 100 transplant hospitals, could potentially use an IAB today as their initial level of circulatory support in the U.S. Based on Abiomed’s internal testing during 510(k) clearance of its IAB, the company believes its IAB has the fastest inflate-deflate time, and best performance relative to abrasion resistance and triggering. The iPulse should be a more cost-effective system for heart hospitals by supporting procedures with associated Medicare reimbursement that extends across four diagnostic-related groups (DRGs) ranging from approximately $20,000 to $215,000 per patient stay.
The current installed base of Abiomed’s AB5000 Circulatory Support System, prior to the approval of the iPulse, is comprised of approximately 50% of the U.S. transplant hospitals and approximately 20% of the U.S. open heart hospitals. Abiomed’s iPulse is also approved in Europe under CE-mark. For additional information please visit www.abiomed.com.
Scholarship Fund Established for RPA/RAs at Weber State University
As of January 2008, several anonymous donors have established the Dr. Harvey Aaron Koolpe Award of Excellence for Radiology Practitioner Assistants (RPAs) through the Dumke College of Health Professions Radiologic Sciences Department, Weber State University, Ogden, Utah. The first award will be presented in 2009 to a graduating RPA student, who achieves at least a GPA of 3.7; is a team leader in his (her) class; writes and has published his (her) required thesis in medical journal or magazine; and receives three outstanding evaluations from three sponsoring physicians, who functioned as clinical advisors during the student’s two-year residency.
This scholarship award has been set up through benefactors to recognize Dr. Koolpe, who passed away on October 18, 2007 from major complications following extensive lower back surgery. This physician was a terrific educator, medical device inventor, and an accomplished cardiovascular medical imaging physician. He completed his radiology residency under the tutelage of Dr. Constantin “Stan” Cope in Philadelphia, Pennsylvania. Then this late pioneer finished his cardiovascular medical imaging fellowship under the directorships of Dr. Manuel Viamonte, Jr. and Dr. James R. LePage in Miami, Florida. His involvement with the RPAs began in 2005, when he was invited to speak at the Sixth Annual National Society of Radiology Practitioner Assistants (NSRPA) in Las Vegas, Nevada. From this experience, he became more involved with the movement as an annual lecturer. He also was as an advocate, helping RPAs to be recognized and accepted by the practicing radiologists and other physicians performing medical imaging procedures in medical facilities that lacked adequate physician and advanced level medical imaging physician extenders. A panel which abides to the policies and procedures set forth by the university for such establishments has been formed. Friends and peers who have an interest in the scholarship may contact Ms. Rebecca Ory Hernandez, Weber State University Alumni Office, Weber State University, 3850 University Circle, Ogden, Utah 84408. If more information is needed, she can be contacted by phone at (801) 626-6566 or by e-mail at firstname.lastname@example.org.