View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
February 22, 2015

FDA approves Medtronic’s VenaSeal closure system to treat varicose veins

Medtronic has received approval from US Food and Drug Administration (FDA) for the VenaSeal closure system.

Leg

Medtronic has received approval from US Food and Drug Administration (FDA) for the VenaSeal closure system.

Free Report
img

Find the right pricing strategy for your medical device

How do your competitors set prices in different markets? Will reducing your prices win market share from your main competitors? Do you need to position products differently for different markets? To find out, use our Global Brand Pricing tool to achieve optimal pricing for your devices. Detect price changes, understand competitor market positioning, and plan new product launches, by accessing this tool today. It features:
  • A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
  • Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
  • Medical device pricing data that can be tracked by market, company, and brand
  • Additional categories that can be built on a custom basis
Use our tool to access competitor pricing strategies across multiple geographies, and various dynamic case studies from the likes of Germany and China, to benchmark yourself against your competitors and future proof your pricing strategies.
by GlobalData
Enter your details here to receive your free Report.

It is the first device that uses adhesive to cut off blood supply in the treatment of superficial varicose veins of the legs.

The VenaSeal sterile kit includes an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guide wire, dispenser gun, dispenser tips, and syringes.

FDA Center for Devices and Radiological Health, Office of Device Evaluation acting director Dr William Maisel said: "This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition.

"Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising."

Approval was granted after the FDA reviewed data for the VenaSeal system in a premarket approval application, which included results from three clinical studies.

In the US clinical study, the VenaSeal system’s safety and effectiveness was assessed in 108 participants compared to radiofrequency ablation in 114 participants.

The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs. It received regulatory approval in Europe in 2011.

The VenaSeal closure system is manufactured by Covidien, which was purchased by Medtronic for $43bn in January.


Image: A person affected by varicose veins. Photo: courtesy of Wikimedia Commons user self.

Related Companies

Free Report
img

Find the right pricing strategy for your medical device

How do your competitors set prices in different markets? Will reducing your prices win market share from your main competitors? Do you need to position products differently for different markets? To find out, use our Global Brand Pricing tool to achieve optimal pricing for your devices. Detect price changes, understand competitor market positioning, and plan new product launches, by accessing this tool today. It features:
  • A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
  • Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
  • Medical device pricing data that can be tracked by market, company, and brand
  • Additional categories that can be built on a custom basis
Use our tool to access competitor pricing strategies across multiple geographies, and various dynamic case studies from the likes of Germany and China, to benchmark yourself against your competitors and future proof your pricing strategies.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network