PR Newswire
19 Sep 2022, 14:20 GMT+10
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).
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 Nanolute 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.
SOURCE Concept Medical
Get a daily dose of Philippine Times news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Philippine Times.
More InformationWASHINGTON D.C.: Reuters has reported that on 7th June, former Vice President Mike Pence will enter the race for the ...
PYONGYANG, North Korea: North Korea attempt failed to launch a satellite on May 31, which prompted raid sirens and a ...
HONG KONG, China: Describing the lack of women in China's top leadership as concerning, the United Nations has recommended the ...
BEIJING, China: Amid its rivalry with the US for reaching new milestones in space, reflecting their competition for global influence, ...
WASHINGTON D.C.: A Transportation Security Administration (TSA) report released this week revealed that over the Memorial Day weekend, the start ...
KUALA LUMPUR, Malaysia: Malaysia's maritime agency has said that it found a cannon shell believed to be from World War ...
MENLO PARK, California: Facebook parent company Meta Platforms has said it would remove news content in California if the state ...
BRUSSELS, Belgium: EU tech chief Margrethe Vestager has said that a draft code of conduct on artificial intelligence (AI) could ...
MOSCOW, Russia: After a turbulent 15 months of store closures and declining demand, Russian designers and brands are assisting the ...
WASHINGTON D.C.: The Federal Communications Commission (FCC) has said that more than 8.3 million US homes and businesses do not ...
CHICAGO, Illinois: Driven by an ongoing shortage of properties available on the market, in March US single-family home prices rose ...
MIAMI, Florida: Carnival Cruise Lines has said a cruise ship, the Carnival Sunshine, which sailed through rough seas off the ...