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UPDATE: Medtronic plc: FDA Approves the VenaSeal Closure System for Treatment of Clinically Symptomatic Venous Reflux


Medtronic plc today announced U.S. Food and Drug
Administration approval for VenaSeal(TM) closure system, a minimally invasive
procedure that uses a specially formulated medical adhesive to close lower
superficial extremities such as the great saphenous vein in patients with
symptomatic venous reflux.

Venous reflux disease, also known as chronic venous insufficiency, occurs when
valves in the veins of the lower leg no longer function properly. This allows
blood to flow backward, or reflux, resulting in enlarged, or varicose veinsas
well as other symptoms. If left untreated, the condition can progress and, in
severe cases, can result in lifestyle-limiting lower leg pain, swelling, skin
damage and ulcerations.^

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The VenaSeal procedure is the only non-tumescent, non-thermal, non-sclerosant
procedure approved for use in the U.S. that uses a specially formulated
medical adhesive that closes the vein. This unique approach may eliminate the
risk of nerve injury that is sometimes associated with certain thermal-based
procedures.^2 The procedure is administered without the use of tumescent
anesthesia, minimizing the need for multiple needle sticks.^2,3 Patients also
report minimal-to-no bruising post procedure. ^4

"The VenaSeal system is an advanced varicose vein procedure that delivers
results that are comparable to current methods," said Dr. Nick Morrison,
national principal investigator of the VeClose Trial, Morrison Vein Institute,
Scottsdale, Ariz. "As the patient does not require multiple injections of a
local anesthetic (tumescent anesthesia), there is minimal to no bruising and
patients are often able to quickly return to normal activities."

The VenaSeal procedure is shown to be safe and effective, with consistent
results across three clinical trials. Closure rates in the first in human
trial were 92 percent at 12 and 24 months, respectively.^3,5 Results from the
European Sapheon Closure System Observational ProspectivE (eSCOPE) study
published in the Journal of Vascular Surgery demonstrate a cumulative closure
rate of 92.9 percent and improvement in quality of life scores at 12 months.^2
Additionally, the three month results of the VeClose pivotal study published
in the Journal of Vascular Surgery in January continue to demonstrate safety
and efficacy of the VenaSeal procedure with excellent closure rates of 98.9

"The FDA approval of the VenaSeal system strengthens our endoVenous portfolio,
providing physicians and their patients with a non-tumescent treatment
option," said Sandra Lesenfants, vice president and general manager of
the endoVenous franchise in Medtronic's Aortic and Peripheral Vascular
business. "The VenaSeal System, together with our Venefit(TM) procedure,
provides physicians and patients with leading treatment options."

The VenaSeal system is currently approved in the U.S., Australia, Canada,
Europe and Hong Kong, and more than 2,000 patients have been treated with the
system. U. S. launch of the VenaSeal system is expected this spring.


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