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September 30, 2020

Surgical Innovation Associates secures CE Mark for absorbable mesh

US medical technology company Surgical Innovation Associates (SIA) has secured CE Mark approval for its absorbable mesh, called DuraSorb.

US medical technology company Surgical Innovation Associates (SIA) has secured CE Mark approval for its absorbable mesh, called DuraSorb.

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The mesh offers mechanical support and scaffolding during the early months of wound healing and scar formation. It is gradually absorbed into the body in one year, leaving the patient free of foreign material.

The CE mark approval enables DuraSorb to be used for reconstructive and aesthetic purposes, including abdominal hernia prophylaxis, breast tissue support, and prosthetic breast support.

SIA noted that its technology adds great value in European hospital systems, as it offers a vital alternative to biologic meshes or permanent synthetic meshes.

Surgeons often try to avoid permanent mesh products, while human or animal-based biologic meshes are generally scarce due to safety concerns and high costs.

SIA president and CEO Dr Alexei Mlodinow said: “It is important that we expand access to our products for plastic and reconstructive surgeons and their patients beyond our own borders here in the US.

“We are excited to work with one of several potential partners across the pond to introduce DuraSorb in Europe and, in the future, other markets.”

SIA’s absorbable mesh has been designed by surgeons, textile experts and polymer scientists.

It received initial 510(k) clearance from the Food and Drug Administration (FDA) for soft tissue support in 2018. Last year, the product was used clinically within a post-market registry.

The company began the US commercial efforts for DuraSorb earlier this year.

Currently, no mesh product has approval from the US FDA for any breast procedure.

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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.

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