Breakthrough Clinical Results Reveal Extended Retrieval Times for Cook Medical's Gunther Tulip(TM) Vena Cava Filter
Results Presented at the Society of Interventional Radiology Meeting Show a 94 Percent Success Rate of Retrieval of Cook's Gunther Tulip up to 12 weeks After Implantation
BLOOMINGTON, Ind.--(HSMN NewsFeed)--A non-randomized, prospective study by H. Bob Smouse, MD that examined the times in which Cook Medical's Gunther Tulip(TM) 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 Illinois 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 Gunther Tulip(TM) 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 Gunther 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 Gunther 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 Gunther 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 participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry magazine. For more information, visit www.cookmedical.com.
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