Cardiac device company AVR is developing the world’s only balloon-expandable, single-piece transcatheter aortic valve called the DurAVR THV device.
AVR recently announced its trademarked device has been implanted in a second successful Valve-in-Valve (ViV) procedure as part of Health Canada’s Special Access Program (SAP).
A ViV procedure becomes necessary for patients where their existing bioprosthetic aortic valve is failing due to calcification or structural decline.In such cases, a new heart valve must be inserted within the malfunctioning valve with the patients at a heightened risk for further surgical interventions and requiring a minimally invasive treatment choice.
Currently marketed products might result in patients remaining in an unhealthy state after the procedure, marked by unsatisfactorily high pressure gradients.
Canada’s Special Access Program (SAP) exists to enable the provision of life-saving technologies not yet commercially accessible in Canada, when no other available alternatives are appropriate.
Dr Janar Sathananthan, an interventional cardiologist at Vancouver General and St Paul’s Hospital, renowned globally for testing the hemodynamic impacts of different valves used in ViV procedures, has formally petitioned Health Canada to authorise use of DurAVR THV.
“It’s quite an exceptional company with a medical advisory board of the who’s who of the cardiovascular space,” Pachacz says. He says AVR has had some exceptionally good results in an early feasibility study with plans for a pivotal study involving around 200 patients.
“There’s two main competitors – Edwards Lifesciences and Medtronic,” he says.“So this company will probably get acquired at some point by one of those two companies, I would’ve thought.”
AVR Price at posting:
$19.01 Sentiment: Buy Disclosure: Held
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