ARCHIVED - Bypassing blocked arteries
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October 01, 2008— Winnipeg, Manitoba
A medical devices supplier specializing in the diagnosis and treatment of peripheral arterial disease (PAD) is now manufacturing its own equipment to expand into new markets, with support from NRC.
Housed at the NRC Institute for Biodiagnostics (NRC-IBD) in Winnipeg, Koven Technology Canada has developed and received regulatory approval to sell an adjustable "valvulotome" for treating PAD — peripheral artery obstructions often found in the legs or feet of elderly patients with type II diabetes. The firm developed its valvulotome with help from the NRC Industrial Research Assistance Program (NRC-IRAP) and NRC-IBD.
|A valvulotome features tiny blades on a catheter to cut out vein valves.|
"If an arterial obstruction can't be cleared up using methods like balloon angioplasty, surgeons often try to bypass the blockage to restore good blood flow using a valvulotome," says Ian Maclean, project manager for Koven Technology Canada. "A valvulotome goes into an adjacent vein and removes the valves, which regulate blood flow, so the vein can function as an arterial graft, taking blood from the heart to the extremities. A successful procedure generally gives a patient at least five pain-free years."
Unlike conventional valvulotomes, the Koven instrument can work on any size of vein. "People's veins usually vary in size throughout their leg, so surgeons have traditionally needed several different instruments to complete a procedure," says Maclean. "But using our valvulotome, a surgeon only needs one instrument."
Maclean says NRC provided invaluable assistance. "We received financial support and guidance on manufacturing, device validation and regulatory approval from NRC-IRAP," he notes. "And without access to NRC-IBD facilities, such as its surgical suites, we would have needed to outsource some product development work at greater cost."
Earlier this year, Koven received regulatory approval to sell its product in Europe and Canada. "And we hope to have U.S. Food and Drug Administration approval this fall," he adds. "We aim to produce at least 5,000 units in the first year."
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