View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
January 27, 2013

Medtronic wins CE mark for Complete SE stent for use in lower extremities

The European Union has granted CE mark certification to Medtronic's self-expanding vascular stent for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs.

By admin-demo

MEDTRONIC

The European Union has granted CE mark certification to Medtronic’s self-expanding vascular stent for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs.

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.

Featuring a delivery system, the Complete SE stent expands the interior diameter of narrowed peripheral arteries and restores normal blood flow.

The approval is based on positive results from the adjudicated single-arm, multicentre Complete SE SFA study, which enrolled 196 patients in which 45% were diabetic, 50% had lesions in the distal segment of the SFA/PPA, 56% of the lesions were defined as highly calcified and 67% of them had a Rutherford Category rating of three or higher.

The results demonstrated that more than 80% of study subjects had achieved a Rutherford Category value of 0 or 1, the favourable end of the 0-6 scale, at 30 days, and that benefit persisted through six months and one year of follow-up.

Results also demonstrated highly significant positive shifts in mean ankle brachial index (ABI) or toe brachial index (TBI) scores at six and 12 months, with 65% of study subjects improving by at least 0.15% over the follow-up period, according to the company.

In addition, on walking assessment measures, patients’ impairment was improved by 37%, distance by 33%, speed by 22% and stair climbing by 23%.

The Complete SE study, when compared to similar studies utilising bare-metal stents in the vessel bed, also showed 0.0% stent fractures at 12 months.

In the US, the Complete SE stent is currently available for use in the iliac arteries, which supply blood to the pelvis and legs.

Medtronic said the use of the Complete SE stent in lower-extremity arteries in the US is under review by the FDA.


Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha’Eri.

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