Medtronic Receives FDA Clearance of New Lower Profile HawkOne 6F Directional Atherectomy System
October 24 2016 - 10:00AM
New Technology
Expands Treatment Options for Patients with Peripheral Artery
Disease Both Above and Below the Knee
DUBLIN - Oct. 24, 2016 -
Medtronic plc (NYSE: MDT) has received U.S. Food and Drug
Administration (FDA) 510(k) clearance for the HawkOne(TM)
Directional Atherectomy System in a new size for treating patients
with peripheral artery disease (PAD). The HawkOne system is
designed to remove plaque from the vessel wall and restore blood
flow. The new HawkOne 6 French (6F) provides an effective and
easy-to-use treatment option for patients with PAD both above and
below the knee with a single device at a lower profile.
PAD is a serious, chronic condition that affects
more than 200 million people worldwide1 and 12
million in the United States.2 In PAD,
arteries in the legs become narrowed or blocked by
plaque. This narrowing of the blood vessel can cause reduced
blood flow to the leg, which can result in severe pain and limit
physical mobility. When blocked arteries are below the knee, they
are more likely to be calcified, and linked to lower treatment
success.3 Patients with
blocked arteries below the knee may also develop the most severe
form of PAD, critical limb ischemia (CLI), which can result in
non-healing leg ulcers and increased risk of amputation.4,5
"Considering the complex disease pattern seen in
below-the-knee PAD, traditional treatment options such as placement
of permanent stents or treatment with a balloon, may not be ideal
for achieving long-term results. Directional atherectomy, on the
other hand, is an established intervention that not only restores
patency but also maximizes luminal gain while keeping future
treatment options open," said Brian DeRubertis, M.D., associate
professor of surgery at the David Geffen School of Medicine at
UCLA. "The new, smaller HawkOne 6F device further adds to the
versatility of this directional atherectomy system and enables us
to treat a larger set of patients with more complex lesions,
including patients with challenging calcified lesions."
The HawkOne 6F size is an advanced option to treat
patients with multi-level PAD both above and below the knee,
addressing lesions of various length, morphology, and location. Key
benefits of the system include:
- Treating calcified lesions:
The HawkOne system enables physicians to treat severe calcified
lesions more efficiently with no increase in cut depth. The system
can treat calcified lesions up to two times more effectively than
the TurboHawk(TM)device.6
- Ease of use: The HawkOne
system has a preloaded flush tool, which improves cleaning time by
up to 55 percent when compared to the TurboHawk high efficiency
cutter.7 The 6F size
is also designed to simplify device selection and provide easy
set-up with no capital equipment.
"The expansion of our HawkOne system provides
physicians with more options to optimize directional atherectomy as
an approach to PAD management, particularly for lesions below the
knee," said Mark Pacyna, vice president and general manager of the
Peripheral business, which is part of the Aortic & Peripheral
Vascular division at Medtronic. "The HawkOne 6F clearance, as well
as the recent approval of our 150mm length IN.PACT(TM) Admiral(TM)
drug-coated balloon and clearance of the Trailblazer(TM) angled
support catheter, reflects our commitment to a full portfolio of
products to meet the needs of patients and physicians."
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 Directional
Atherectomy
The new 6F HawkOne expands Medtronic's directional atherectomy
portfolio, which also includes the TurboHawk and SilverHawk(TM)
systems and is backed by more than 15 peer-reviewed
studies.8 These include
DEFINITIVE LE, the largest independently-adjudicated study of an
atherectomy procedure ever conducted, and DEFINITIVE AR, a pilot
study, and the first randomized look into the effects of preparing
a vessel with directional atherectomy followed by treatment with a
drug-coated balloon (DCB).
Results from DEFINITIVE LE demonstrated 95 percent
limb salvage in patients with critical limb ischemia (CLI) and 78
percent overall patency in claudicant patients 12 months post
treatment.9 A subset
analysis of DEFINITIVE LE in claudicant patients with
infrapopliteal disease observed 12-month patency rates of
approximately 90 percent.9 Both
DEFINITIVE LE and DEFINITIVE AR showed low dissection and
provisional stent rates when patients were treated with directional
atherectomy.10
Furthermore, directional atherectomy can also be
used as an adjunctive treatment prior to using the Medtronic
IN.PACT Admiral drug-coated balloon.
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 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
1 Fowkes, F.
G., et al. (2013). Lancet 382(9901): 1329-1340.
2 Goodney, P.
P., et al. (2015). JAMA Surg 150(1): 84-86.
3 Roberts, D.,
et al. (2014). Catheter Cardiovasc Interv 84(2): 236-244.
4 Dua, A. and
C. J. Lee. (2016). Tech Vasc Interv Radiol 19(2): 91-95.
5 Liistro, F.,
et al. (2013). Circulation 128(6): 615-621.
6 Medtronic
data on file.
7 Medtronic
data on file.
8
Medtronic data on file.
9 McKinsey, J.
F., et al. (2014). JACC Cardiovasc Interv 7(8): 923-933.
10 Zeller, T.
(2014). DEFINITIVE AR, VIVA 14.
Contacts:
Krystin Hayward
Public Relations
+1-508-298-8246
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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