Medtronic gets Health Canada licence for IN.PACT Admiral drug-coated balloon
Medtronic Canada has secured licence from Health Canada for its IN.PACT Admiral drug-coated balloon (DCB), which helps reopen blood vessels in legs narrowed by peripheral artery disease (PAD).
Admiral DCB is a primary endovascular device, which will be used to treat patients with peripheral artery disease (PAD) in the upper leg, specifically in the thigh (superficial femoral arteries) and behind the knee (popliteal arteries).
Under the procedure, the compressed balloon will be inserted into the artery and expands the balloon to re-open the blockage. Later, it will be removed.
Compared to traditional alternatives like stents or plain balloons, DCB is said to leave behind medication to help prevent the artery from narrowing (restenosis).
IN.PACT Admiral includes coating formulation, which is comprised of an anti-proliferative drug (paclitaxel) and an excipient (urea).
Once expanded, the coating will get into contact with water in the bloodstream that hydrates the urea, enabling to release solid-phase paclitaxel to the vessel wall to prevent restenosis.
According to Medtronic, IN.PACT Admiral DCB was studied in more than 20 individual clinical trials, which showed durable safety and clinical benefits.
Medtronic Canada cardio vascular group senior director Michael Blackwell said: "What many people don't realize is that PAD in the legs is often connected to health conditions in other parts of the body, especially in the heart.
"With drug-coated balloons, we now have a way to more effectively reduce plaque build-up caused by PAD, and we are excited that hospitals in Canada are now able to offer this new technology."
Image: IN.PACT Admiral DCB enables to reopen blood vessels in legs narrowed by peripheral artery disease. Photo: courtesy of CNW Group / Medtronic of Canada, Ltd.