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News

Cook Gunther Tulip Vena Cava Filter offers extended safe retrieval times

Cook : 26 April, 2007  (New Product)
A clinical study of Cook's Gunther Tulip Vena Cava Filter shows that the device 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).
A non-randomised, prospective study by H Bob Smouse, MD that examined the times in which Cook Medical's Gunther Tulip Vena Cava Filter could be successfully retrieved from patients presented the results.

Dr Smouse, who works at the University of Illiniois College of Medicine at Peoria, served as the National Principal Investigator for the multi-centre study, which was presented at the 2007 Society of Interventional Radiology (SIR) annual meeting.

'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 vena cava filters must measure up to'.

The Gunther Tulip Vena Cava Filter received Food and Drug Administration 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 clearly demonstrates the versatility afforded to clinicians who choose the Gunther Tulip Filter for their patients' said Rob Lyles, Global Leader of Cook Medical's Peripheral Intervention products division.

'The option to place the filter permanently or to retrieve it up to 12 weeks with such a high degree of success gives clinicians and their patients a lot of flexibility in tailoring a therapeutic regimen to prevent PE'.

The prospective study initiated enrollment on 9 February 2005 and closed enrollment on 31 July 2006.

555 patients were enrolled at 25 US based investigational institutions
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