New, Innovative
Technology Brings Relief to Patients Suffering with Varicose
Veins
DUBLIN - November 9, 2015 -
Medtronic plc (NYSE: MDT) today announced U.S. availability of the
VenaSeal(TM) closure system, the first and only non-tumescent,
non-thermal, non-sclerosant procedure approved for the treatment of
symptomatic venous reflux in the U.S. The VenaSeal closure system
was approved through the FDA's Pre-Market Approval (PMA) process,
and is a minimally invasive procedure that uses a proprietary
medical adhesive to close superficial veins of the lower
extremities, such as the great saphenous vein, in patients with
symptomatic venous reflux.
"Patients are often told their varicose veins are
only a cosmetic issue, but varicose veins are a sign of a condition
known as venous insufficiency, which can cause symptoms that impact
quality of life, and over time can lead to more serious problems,"
explained Kathleen Gibson, M.D., Lake Washington Vascular, Seattle,
who performed the first treatment of a U.S. patient on October 21,
2015 with the VenaSeal closure system since approval. "Left
untreated the venous insufficiency often progresses, and can cause
leg pain, leg and ankle swelling, leg heaviness and fatigue, skin
changes or rashes, ulcers and open wounds."
Venous insufficiency occurs when valves in the
veins of the leg no longer function properly. This disease allows
blood to flow backward, or reflux, resulting in enlarged, or
varicose veins that become painful and can limit quality of life.
Venous insufficiency affects more than 30 million Americans and is
common in women who have had two or more pregnancies.
"The first patient is an active, tennis-playing
mother of three with a family history of varicose veins. After
careful diagnosis and evaluation of various treatment options, she
and I decided VenaSeal was the right choice of treatment for her.
She reported no pain during the procedure and was able to return to
normal activities quickly after the treatment. She left the office
with a single adhesive bandage at the site of treatment, and
without post-procedure compression stockings*," said Dr.
Gibson.
Using ultrasound, the physician guides a catheter
through a small access site in the leg and into the diseased area
of the vein. Once in place, the physician administers the
VenaSeal(TM) adhesive at various points in a segmental fashion, and
with manual compression, closes the vein. Blood is re-routed
through other healthy veins in the leg.
This unique approach eliminates the risk of
burning or nerve injury that is sometimes associated with
thermal-based procedures. The procedure is administered without the
use of tumescent anesthesia, minimizing the need for multiple
needle sticks. In the VeClose trial, patients reported minimal - to
- no pain or bruising, post procedure.
"The VenaSeal procedure is shown to be safe and
effective, with consistent results across three clinical trials,"
said Dr. Nick Morrison, national principal investigator of the
VeClose Trial, Morrison Vein Institute, Scottsdale, Ariz. "One-year
results of the VeClose pivotal study, that led to the approval of
VenaSeal closoure system in the U.S., continue to demonstrate
safety and efficacy of the procedure, with closure rates of 97.2
percent."
"Medtronic today furthers our commitment to
providing treatment options for patients with symptomatic venous
reflux, a disease that can significantly impact quality of life,"
said Sandra Lesenfants, vice president and general manager of the
endoVenous business in Medtronic's Aortic and Peripheral Vascular
division. "Thousands of patients have benefited from this procedure
around the world, and we are pleased to now offer this advanced
technology as an option to our U.S. physicians and patients."
The VenaSeal system is currently available in the
U.S., New Zealand, Chile, South Africa, Australia, Canada, Europe,
United Arab Emirates and Hong Kong. To learn more visit:
www.medtronic.com/endovenous
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 85,000 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.
*Some patients may benefit from the use of
compression stockings post-procedure
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-
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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