AUSTRALIAN ASSOCIATED PRESS
  • TRUSTED
  • ACCURATE
  • IMPARTIAL
DONATE SUBSCRIBE

MagicTouch SCB receives IDE approval for In-Stent Restenosis indication

PRNewswire September 19, 2022

TAMPA, Fla., Sept. 19, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR).

World's first IDE approved Sirolimus Coated Balloon in Coronary - MagicTouch SCB

US FDA’s IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to support safety and effectiveness of this combination product. The data generated from this IDE clinical study will support a pre-market approval (PMA) application in the USA.

MagicTouch SCB is the world’s first Sirolimus-coated Balloon with extensive commercial usage in Europe, major markets of Asia and the Mid-Eastern markets. More than 100 thousand patients have been treated with MagicTouch SCB in these markets.

About MagicTouch SCB:

MagicTouch SCB is a CE marked and commercially marketed Sirolimus coated balloon developed by Concept Medical, using proprietary Nanoluté Technology. MagicTouch SCB has been used in >50,000 patients in major global markets.

About Concept Medical Inc (CMI):

CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.

www.conceptmedical.com

Concept Medical Logo

 

SOURCE Concept Medical

Keep updated

Latest Releases

Latest News

AAPR aggregates press releases and media statements from around the world to assist our news partners with identifying and creating timely and relevant news.

All of the press releases published on this website are third-party content and AAP was not involved in the creation of it. Read the full terms.

AAP FactCheck

  • Information you can trust
  • Written by trained, experienced journalists using authoritative sources
  • Accredited by the International Fact-Checking Network (IFCN)

AAP FactCheck provides factual, authoritative information Australians can rely on. Accredited with the Poynter Institute's International Fact-Checking Network and adhering to the highest industry standards, our experienced team works to minimise the impact of misinformation.

AAP Photos

  • Award-winning Australian Photography
  • Editorial or Commercial use
  • Subscriptions or one-off licences

Image buyers from all industries rely on AAP Photos. A digital treasure trove of content depicting Australian life, our fully-searchable database contains millions of images from around the country and around the world.

AAPNews

  • News delivered to your inbox
  • Trusted, reliable and accurate
  • Corporate and individual packages available

AAPNews delivers newswire content direct to the public. Choose from a number of subscription models to not only gain access to high-quality fact-based news on your desktop or mobile device, but also to show your support for Australia's only not-for-profit newswire.

Newsroom

  • The wire – up to the minute news at your fingertips
  • Feeds delivered to your CMS
  • Agenda – AAP’s planning and events tool

Get the news feed your organisation needs, with AAP offering extensive coverage of news, courts, politics, sports, finance and the arts. Take advantage of AAP’s partner content to get the international news that matters to your business, with news feeds delivered via multiple channels including API and FTP.