Breakthrough Clinical Results Reveal Extended Retrieval Times for Cook Medical’s Günther Tulip™ Vena Cava Filter
March 29, 2007
Bloomington, Ind., March 29, 2007 – A non-randomized, prospective study by H. Bob Smouse, MD that examined the times in which Cook Medical’s Günther Tulip™ Vena Cava Filter could be successfully retrieved from patients has presented breakthrough results, Cook officials reported today. Dr. Smouse, who works at the University Of Illiniois College Of Medicine at Peoria, served as the National Principal Investigator for the multi-center study, which was presented at the 2007 Society of Interventional Radiology (SIR) annual meeting. Clinical study results revealed that Cook Günther Tulip™ Vena Cava Filter can be safely retrieved up to 12 weeks post-implant with a success rate of 94 percent when used for prevention of pulmonary embolism (PE).
“This clinical study, which is the largest to examine vena cava filter retrievals, reveals breakthrough results about physicians’ ability to retrieve Cook’s Günther Tulip months after implantation,” said Dr. Smouse. “Our hope is that these results become the criterion to which all retrievable vena cava filters must measure up to.”
The Günther Tulip Vena Cava Filter received Food and Drug Administration (FDA) clearance in October 2000 for permanent placement in patients and in October 2003 for retrievable use. The Günther Tulip is an implanted device used to capture blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a PE.
“This retrieval data is extremely encouraging and demonstrates the medical advancements in treating PEs,” said Rob Lyles, global leader of Cook Medical’s Peripheral Intervention products division. “At Cook, we are continually driving to improve the quality of our products and in turn, improve the quality of patient outcomes.”
The prospective study initiated enrollment on February 9, 2005 and closed enrollment on July 31, 2006. 555 patients were enrolled at 25 U.S. investigational institutions.
About Cook Medical
Cook Medical was the first company to introduce interventional devices in the United States. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.