Medtronic Unveils
Data for VenaSeal Closure System at Charing Cross and the
International Vein Congress
DUBLIN - April 28, 2016 -
This week at the 2016 Charing Cross Symposium in London and the
International Vein Congress in Miami, Medtronic plc (NYSE: MDT)
unveiled clinical data for the VenaSeal(TM)
closure system demonstrating consistent long-term durability and
improved quality of life in patients with venous reflux disease.
The new data presented included two-year outcomes from the VeClose
pivotal clinical study, with two additional subanalyses evaluating
quality of life and physician ease-of-use; and three-year results
from the European Sapheon Closure System Observational ProspectivE
(eSCOPE) study.
VenaSeal is a non-tumescent, non-thermal,
non-sclerosant procedure that uses a proprietary medical adhesive
to close superficial veins of the lower extremities, such as the
great saphenous vein (GSV), in patients with symptomatic venous
reflux.
"As shown by our unmatched body of Level 1
evidence in the venous industry, Medtronic has demonstrated its
deep-rooted commitment to providing clinically-proven and patient
friendly treatment options for patients with chronic venous
insufficiency," said Sandra Lesenfants, vice president and general
manager of the endoVenous business in Medtronic's Aortic and
Peripheral Vascular division. "We're enthusiastic about the
unveiling of such strong datasets, and we look forward to
continuing to build upon this clinical program."
VenaSeal Two-Year Closure Rates
Meet Gold Standard in Level 1 VeClose Study
New two-year results from the VeClose trial were presented at
Charing Cross by Raghu Kolluri, M.D., medical director of vascular
medicine at Riverside Methodist Hospital in Columbus, Ohio, and by
Kathleen Gibson, M.D., of Lake Washington Vascular in Seattle at
the International Vein Congress.
At two-years, the complete closure of the GSV was
achieved in 94.3 percent of patients treated with VenaSeal compared
to 94.0 percent of patients treated with ClosureFast(TM), showing
continued, similar long-term non-inferiority outcomes
(p=0.0075).
The VeClose U.S. pivotal clinical study is a
prospective, randomized, controlled, non-inferiority study that
compares the safety and effectiveness of the VenaSeal closure
system to the gold standard ClosureFast endovenous radiofrequency
ablation procedure. Two hundred and forty-two patients with
symptomatic refluxing great saphenous veins were enrolled in the
trial. Patients were randomized to receive treatment with VenaSeal
and treatment with ClosureFast.
Subanalysis Demonstrates Improved
Quality of Life with VenaSeal
In a separate session presented by Dr. Gibson at Charing Cross, a
one-year subanalysis from the VeClose trial compared quality of
life improvement factors following treatment with VenaSeal and
ClosureFast. Patient improvement was rated on a Venous Clinical
Severity Score (VCSS) and an Aberdeen Varicose Vein Questionnaire
(AVVQ) that included factors such as age (45-65 years), body mass
index (25-35), gender and the diameter size of the GSV. For
subjects treated with VenaSeal, mean change in VCSS and AVVQ at 12
months compared to baseline was statistically significant at -4.02
(SD 2.48, p<.0001) and -8.8 (SD 7.5, p<.0001), respectively.
Findings showed improvement in VCSS and quality of life across all
ages, body mass index, gender and vein diameter size.
"This randomized trial demonstrates VenaSeal's
ability to provide a safe and effective treatment for patients with
varicose veins," said Dr. Kathleen Gibson. "With excellent outcomes
at two years, VenaSeal offers patients an alternative treatment to
traditional therapies for varicose veins, allowing a rapid recovery
with minimal downtime and diminished post-procedure bruising."
VenaSeal Associated with Minimal
Learning Curve
In a separate session at Charing Cross, a roll-in phase analysis
from the VeClose trial was also presented by Dr. Kolluri. The
subset analysis evaluated the safety and effectiveness of 20
patients treated with the VenaSeal closure system by trained
physicians with no prior VenaSeal device experience. The
roll-in group included the first two patients treated with VenaSeal
at 10 enrolling sites; three-month outcomes were then compared to
the randomized patients treated with VenaSeal and ClosureFast.
Three-month follow-up results show that 19 of the
20 patients returned for follow-up. The investigators achieved
complete closure of the GSV in 100 percent of these follow-up
patients, demonstrating comparable efficacy and safety outcomes to
the randomized patients treated with VenaSeal (99%, n=103) and
ClosureFast (95.4%, n=103).
"Despite having no prior physician experience with
VenaSeal, these data demonstrated remarkable ease-of-use and a
limited learning curve for first-time-users as compared to
experienced users," said Nick Morrison, M.D., Morrison Vein
Institute, Scottsdale, Ariz., and national principal investigator
of the VeClose trial.
High Closure Rates with VenaSeal
Consistent Out to Three Years in eSCOPE Study
Three-year results from the eSCOPE study were also presented today
at Charing Cross by Thomas Proebstle, M.D., PhD, Dept. of
Dermatology, University Medical Center Mainz, Germany. Of the 70
patients treated with VenaSeal, results showed 88.5 percent closure
rate at three years, demonstrating durable and consistent outcomes
over the long term.
eSCOPE is an international, multi-center,
prospective, single arm, observational, post-market study designed
to record the clinical outcomes of the CE (Conformité Européenne) Marked VenaSeal.
About VenaSeal
The unique approach of VenaSeal eliminates the risk of nerve injury
that is sometimes associated with certain thermal-based
procedures.1 The procedure
is administered without the use of tumescent anesthesia, minimizing
the need for multiple needle sticks.1,2 Patients
also report minimal-to-no bruising post procedure.3
The VenaSeal system is currently available in the
U.S., New Zealand, Chile, South Africa, Australia, Canada, Europe,
United Arab Emirates, Hong Kong and Turkey. 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.
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 Proebstle,
TM, Alm J, Dimitri S et al. The European multicenter cohort study
on cyanoacrylate embolization of refluxing great saphenous veins. J
Vasc Surg Venous and Lymphat Disord.
2 Almeida
JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM.
Two-year follow-up of first human use of cyanoacrylate adhesive for
treatment of saphenous vein incompetence. Phlebology / Venous Forum
of the Royal Society of Medicine, 2014.
3 Morrison,
N. et al. Randomized trial comparing cyanoacrylate embolization and
radiofrequency ablation for incompetent great saphenous veins
(VeClose). Journal of Vascular Surgery. January 30, 2015.
DOI: http://dx.doi.org/10.1016/j.jvs.2014.11.071
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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