Medtronic Prevail DCB™ Designed to Treat Complex Lesions with
Superior Deliverability, Rapid Absorption of Paclitaxel
DUBLIN, July 26, 2021 /CNW/ -- Medtronic plc (NYSE:
MDT), the global leader in medical technology, today announced
the launch of the Prevail™ drug coated balloon (DCB) Catheter in
Europe following CE (Conformité
Européene) mark. The newest coronary DCB on the market, the
Prevail DCB is used during percutaneous coronary intervention (PCI)
procedures to treat narrowed or blocked coronary arteries in
patients with coronary artery disease (CAD).
During the catheter-based procedure, the balloon inflates within
the artery, while the drug is delivered to the arterial tissue
where it is absorbed. The Prevail DCB utilizes a rapid absorption
drug – paclitaxel – to enable treatment of de novo lesions, small
vessel disease, and in-stent restenosis (ISR). DCB angioplasty does
not require a permanent implant and is often used in cases where
the implantation of a drug-eluting stent (DES) is not desirable or
is technically challenging.
"As physicians treat more patients with complex lesions, it is
critical to have a drug coated balloon that is highly deliverable
across a variety of vasculatures, and also utilizes a drug that
absorbs quickly into the vessel," said Azeem Latib, M.D., lead principal investigator
of the PREVAIL Study and section head of interventional cardiology
and medical director of structural heart interventions at
Montefiore Medical Center in New York
City. "The excellent deliverability coupled with a strong
safety profile that is backed by clinical evidence makes the
Prevail DCB an ideal option for interventional cardiologists using
DCB technology to treat their patients."
The Prevail DCB builds on the excellent safety and efficacy
demonstrated in the previous generation IN.PACT™ Falcon DCB
clinical program and was reaffirmed by the PREVAIL Study presented
at the 2020 PCR e-Course conference. In the PREVAIL Study, the
Prevail DCB showed exceptional performance in patients with complex
lesions, including those with small vessels and those treated for
in-stent restenosis, which occurs when a portion of a stented
artery is blocked. The Prevail DCB showed favorable late loss (0.05
± 0.44 mm) at 6 months and a strong safety profile that included no
stent thrombosis, target vessel myocardial infarction (TVMI), or
cardiac death and low clinically driven target lesion
revascularization (6%) out to one year for all
patients.1
"The launch of the Prevail DCB not only underscores our global
leadership and commitment to interventional cardiologists around
the world, but also highlights our strong focus on complex PCI,"
said Jason Weidman, senior vice
president and president of the Coronary and Renal Denervation
business, which is part of the Cardiovascular Portfolio at
Medtronic. "We intentionally designed the Prevail DCB to address
the challenges posed by smaller, more complex vessels by leveraging
our coronary technologies to provide physicians the ability to
navigate through tight lesions with greater confidence."
The Prevail DCB uses PowerTrac™, the same enhanced technology
used in the delivery system for the Medtronic Resolute Onyx™ DES,
to provide superior deliverability and two times more pushability
than the previous IN.PACT Falcon technology enabling greater
control for tortuous anatomies.2 In addition, Prevail
DCB has a low crossing profile for exceptional crossability.
The Prevail DCB is the latest addition to the Medtronic coronary
portfolio, which also includes the market-leading Resolute Onyx DES
in sizes ranging from 2.0-5.0 mm, the Euphora™ semicompliant
balloon dilatation catheter, the DxTerity™ Diagnostic Angiography
Catheter line, and the Telescope™ Guide Extension Catheter.
The Prevail DCB is available for use in Europe and is not approved in the
U.S.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
around the world.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland, 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 employs more than 90,000 people worldwide,
serving physicians, hospitals and patients in more than 150
countries. 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 Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
1 Late Loss at 6 months was lower than the
prespecified maximum acceptance rate of 0.5 mm. PREVAIL Study did
not have powered endpoints.
2 Bench testing vs. IN.PACT Falcon 3.00 mm x 20
mm balloon, 2020. Deliverability defined as pushability. Bench test
data may not be indicative of clinical performance.
Contacts:
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SOURCE Medtronic plc