New Medtronic Data Demonstrate Clinical and Quality of Life Benefits for VenaSeal Closure System in Venous Reflux Disease Pat...
April 25 2017 - 11:30AM
Three-Year VeClose
Trial and One-Year WAVES Study Data Presented at Charing
Cross
DUBLIN and LONDON - April 25,
2017 - Medtronic plc (NYSE: MDT) today announced three-year
outcomes from the VeClose U.S. pivotal clinical trial and one-year
data from the WAVES study. Both results were presented by Kathleen
Gibson, M.D., of Lake Washington Vascular in Bellevue, Wash., at
the 2017 Charing Cross Symposium in London. The new data
demonstrate the clinical and quality of life benefits of the
Medtronic VenaSeal(TM) closure system in treating patients with
venous reflux disease.
Three-Year Data from VeClose
Trial
The VeClose U.S. pivotal clinical trial is a prospective,
randomized, controlled trial comparing the safety and effectiveness
of the VenaSeal closure system to the Medtronic ClosureFast(TM)
endovenous radiofrequency ablation (RFA) procedure in a
non-inferiority design. The trial enrolled 242 patients with
symptomatic refluxing great saphenous veins (GSV), of which 222
were randomized 1:1 to receive treatment with VenaSeal or
ClosureFast.
At three-years, the complete closure of the GSV
was achieved in 94.4 percent of patients treated with VenaSeal
compared to 91.9 percent of patients treated with ClosureFast -
showing both the continued long-term, non-inferior outcomes
(p=0.005) and the durability of the treatment.
Additionally, patient improvement was rated on
three assessments: Venous Clinical Severity Score (VCSS), a
clinical venous disease assessment; and the Aberdeen Varicose Vein
Questionnaire (AVVQ) and EQ-5D - both of which provide
patient-reported quality of life scores. In all three assessments,
patients treated with either VenaSeal or ClosureFast reflected
statistically significant improvement from baseline.
"The three-year outcomes for this randomized trial
reinforce the consistent clinical performance of VenaSeal and
ClosureFast," said Dr. Gibson. "These long-term VenaSeal data along
with post-market WAVES study results continue to build on the prior
findings for this innovative treatment option for venous reflux
disease, demonstrating safety, effectiveness, and quality of
life."
One-Year WAVES Study Data
Presented for the First Time
In a separate session at Charing Cross, Dr. Gibson presented the
one-year data from the independent, physician-initiated WAVES
study, demonstrating quality of life impacts along with safety and
effectiveness of the VenaSeal closure system. The single-center
study enrolled 50 patients in a real-world assessment of the
treatment of one or more incompetent truncal veins in a single
setting without mandatory post-operative compression stockings.
Key findings from the WAVES study are summarized
as follows:
- The one-year GSV closure rate for VenaSeal was
100 percent. In comparison, the GSV closure rate for VenaSeal in
VeClose, which required post-operative compression stockings, was
96.8 percent. Further, the mean vessel diameter in WAVES was larger
than in VeClose.
- The mean time for patients' return to work was
0.2 days ± 1.1 days. Furthermore, the mean time for returning to
normal activities, including a patient's exercise routine, was 2.4
days ± 4.1 days.
"The data presented at Charing Cross further
demonstrate the VenaSeal closure system as a safe and effective
therapy for treating venous reflux disease," said Sandra
Lesenfants, vice president and general manager of the endoVenous
business, which is part of the Cardiac and Vascular Group at
Medtronic. "Together with the clinical community, we look forward
to continuing our investment in clinical research to support the
use of this innovative, minimally invasive treatment for venous
reflux disease."
About VenaSeal Closure
System
VenaSeal closure system 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.
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-
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq 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
Medtronic (NYSE:MDT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Sep 2023 to Sep 2024