IN.PACT™ Admiral™ Drug-Coated Balloon (DCB)
Helps Reopen Blood Vessels in Legs Narrowed by Peripheral Artery
Disease; Medtronic Launches IN.PACT Admiral DCB in Canada
BRAMPTON, ON, Feb. 9, 2017 /CNW/ - Medtronic Canada, a
subsidiary of Medtronic plc (NYSE:MDT), announced it has obtained
Health Canada licence for the IN.PACT Admiral Drug-Coated
Balloon (DCB). IN.PACT Admiral DCB is a primary endovascular device
used in patients with peripheral artery disease (PAD) in the upper
leg – specifically, in the thigh (superficial femoral arteries) and
behind the knee (popliteal arteries).
Affecting an estimated 800,000 people in Canada, PAD is a debilitating disease that
occurs when arteries become narrowed or blocked by plaque build-up,
restricting blood flow.1
The procedure involves inserting a compressed balloon into the
artery, inflating the balloon to re-open the blockage, and then
removing it. But unlike traditional alternatives like stents or
plain balloons, the DCB leaves behind medication designed to help
prevent the artery from narrowing (restenosis).
What distinguishes the IN.PACT Admiral DCB from other
alternatives for PAD is the coating formulation, composed of a
proven anti-proliferative drug (paclitaxel) and an excipient
(urea). Once inflated, the coating comes into contact with water in
the bloodstream, which hydrates the urea, facilitating the release
of solid-phase paclitaxel to the vessel wall to help prevent
restenosis.
"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," said Michael
Blackwell, senior director of Medtronic's CardioVascular
Group in Canada. "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."
PAD commonly affects arteries in the upper legs and can cause
recurrent and painful muscle cramping in the thigh and/or upper
calf. The pain can be described as dull, causing heaviness or
tightness in the muscles, but often will stop when the person is at
rest. Experiencing pain, even while at rest or while sleeping is
often a sign of a more severe disease. If not properly treated, PAD
can lead to life-threatening complications, and is associated with
a four to five times higher risk for heart attack or
stroke.2
Supported by a robust body of evidence, IN.PACT Admiral DCB has
been studied in more than 20 individual clinical trials
demonstrating durable safety and clinical benefits. Recently,
three-year data from the IN.PACT SFA clinical trial shared at the
2016 Vascular Interventional Advances (VIVA) Conference
demonstrated the highest rate of primary patency and lowest rate of
clinically driven target lesion revascularization in a pivotal
study of interventional treatments for
PAD.3
"Patients experiencing incapacitating intermittent claudication
or rest pain need a safe and durable treatment option," said Dr.
Andrew Benko, Centre Hospitalier
Universitaire de Sherbrooke
(CHUS). "In my practice, IN.PACT Admiral DCB will be the device of
choice for such patients with femoropopliteal lesions giving the
opportunity for outstanding clinical results with very low
reintervention rates. This technology has been one of the most
significant advancements I have seen in the endovascular management
of PAD."
About Medtronic
Medtronic Canada (www.medtronic.ca),
headquartered in Brampton, Ontario
is a subsidiary of Medtronic plc, which is among the world's
largest medical technology, services and solutions companies —
alleviating pain, restoring health and extending life for millions
of people around the world. Medtronic is proud to employ over 1,600
people in Canada, serving
physicians, hospitals and patients across the country. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward looking statements are subject to
risks and uncertainties such as those described in
Medtronicʹs periodic reports on file with
the Securities and Exchange Commission. Actual results may
differ materially from anticipated results.
_____________________________________
1 National Heart Lung And Blood Institute (Nhlbi). Facts
About Peripheral Arterial Disease (P.A.D.) (n.d.): n. pag. Web.
2 Aboyans, Victor, Ileana Desormais, Philippe Lacroix, Johanna Salazar, Michael
H. Criqui, and Marc Laskar.
"The General Prognosis of Patients With Peripheral Arterial Disease
Differs According to the Disease Localization." JAMA. 55.9 (2010):
898-903.
3 Krishnan, P., IN.PACT SFA RANDOMIZED TRIAL:
DRUG-COATED BALLOONS SHOW SUPERIOR 3-YEAR OUTCOMES VERSUS STANDARD
ANGIOPLASTY. Vascular Interventional Advances (VIVA) 2016.
SOURCE Medtronic of Canada,
Ltd.