Data Demonstrate Strong Closure Rates in Patients with Chronic
Venous Insufficiency, Varicose Veins
DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 13, 2014--
Covidien plc (NYSE:COV) today announced the six-month results of the
VeClose pivotal study, which demonstrated the safety and effectiveness
of the VenaSeal™ closure system* in patients with chronic venous
insufficiency (CVI) having symptomatic reflux in the great saphenous
vein. The results were presented at American College of Phlebology
Annual Congress (ACP 2014) in Phoenix, Ariz.
The VeClose randomized controlled non-inferiority study compared the
safety and effectiveness of the VenaSeal™ system to that of the
ClosureFast™ endovenous radiofrequency ablation catheter. Covidien’s ClosureFast™
catheter is an endovenous radiofrequency (RF) ablation catheter
designed to collapse and close enlarged leg veins. The VenaSeal™ system,
which is not approved and currently limited to investigational use in
the United States, is a minimally invasive procedure that uses a
specially formulated medical adhesive to close the great saphenous vein.
Additionally, the VenaSeal™ system eliminates the need for surgery,
thermal ablation and tumescent anesthesia.
“The VenaSeal™ system is the latest innovation in the evolution of
minimally invasive treatment options for chronic venous disorders,” said
Dr. Nick Morrison, co-National Principal Investigator for the VeClose
study. “The six-month results of the VeClose study showed high closure
rates, comparable to radiofrequency ablation. I am excited about the
possibility of offering this tumescent-free treatment option to
patients.”
Two hundred and forty-two patients were enrolled in the trial, of which
108 were randomized to receive treatment with the VenaSeal™ system and
114 with the ClosureFast™ catheter. Twenty patients were enrolled as
roll-in/training cases and treated with the VenaSeal™ system. The
results showed outcomes for the VenaSeal™ system comparable with the
excellent closure rates associated with the ClosureFast™ catheter and
demonstrated non-inferiority of the VenaSeal™ system:
-
At three months, the complete closure of the great saphenous veins
achieved in more than 98.9 percent of patients treated with the
VenaSeal™ system compared to 95.6 percent of patients treated with the
ClosureFast™ catheter.
-
The closure rate at six months was 98.9 percent and 94.3 percent for
the VenaSeal™ system and the ClosureFast™ catheter, respectively.
-
Additionally, there were no significant differences in patient
reported pain during or at three days post procedure between the
groups.
Additionally, in October 2014, the Journal
of Vascular Surgery published results from the European Sapheon™
Closure System Observational ProspectivE (eSCOPE) study, which
demonstrated significant improvement in venous symptoms with a
cumulative 12 month closure rate of 92.9 percent. The results also
demonstrated the VenaSeal™ system improves patients’ quality of life.
“The breadth of Covidien’s CVI portfolio provides patients and
physicians the opportunity to have two safe and minimally invasive
treatment options supported by leading clinical evidence,” said Dr. Mark
Turco, chief medical officer, Vascular Therapies, Covidien. “The results
of the VeClose and eSCOPE studies clearly demonstrate the effectiveness
and safety of the VenaSeal™ system along with the previously reported
long term data available for the ClosureFast™ catheter.”
*The VenaSeal™ system is currently approved in Australia, Canada,
Europe and Hong Kong, and more than 2,000 patients have been treated
with the system. The VenaSeal™ closure system is not approved in the
United States, and is currently limited to investigational use.
About Chronic Venous Insufficiency
Chronic Venous Insufficiency (CVI) is a progressive, sometimes
debilitating medical condition. It occurs when valves in the veins of
the lower leg no longer function to push blood back to the heart. This
allows blood to flow backward, or reflux resulting in enlarged, or
varicose, veins. If left untreated, the condition can progress and, in
severe cases, can result in lifestyle-limiting lower leg pain, swelling,
skin damage and ulcerations.1
About Covidien
Covidien is a global health care leader that understands the challenges
faced by providers and their patients and works to address them with
innovative medical technology solutions and patient care products.
Inspired by patients and caregivers, Covidien’s team of dedicated
professionals is privileged to help save and improve lives around the
world. With more than 39,000 employees, Covidien operates in 150-plus
countries and had 2014 revenue of $10.7 billion. To learn more about our
business visit www.covidien.com
or follow us on Twitter.
1 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A.
Blemings, and B. Eklof, Randomized Clinical Trial Comparing Endovenous
Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical
Stripping for Great Saphenous Varicose Veins. British Journal of Surgery
Society Ltd, Wiley Online Library, www.bjs.co.uk,
March 15, 2011.
Source: Covidien plc
Covidien
Krystin Hayward, 508-261-6512
Manager, Communications
Vascular
Therapies
krystin.hayward@covidien.com
or
Peter
Lucht, 508-452-4168
Vice President, External Communications
Corporate
Communications
peter.lucht@covidien.com
or
Coleman
Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Todd
Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com
