MagicTouch SCB receives IDE approval for In-Stent Restenosis indication

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).

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 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.

www.conceptmedical.com

SOURCE Concept Medical

Watch latest videos

News RELEASES

Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Vietnam Tribune.

More Information

20 ℃

Cloudy in Hanoi/Noi Bai

Southeast Asia

Section

Dahal invites UAE's 'vibrant business community' to partner with Nepal for mutual growth

ABU DHABI, UAE - Nepal, according to Prime Minister Pushpa Kamal Dahal 'Prachanda,' requires a significant investment in infrastructure, human ...

Flight to Freedom: 121 Malaysians rescued from Myanmar's battle zone return home

KUALA LUMPUR, Malaysia - According to Malaysia's foreign ministry, 121 people, mostly Malaysians suspected of being victims of job scams, ...

Zardari blames 'some forces' for pulling back leaders with progressive vision

QUETTA, Pakistan - Asif Ali Zardari, Co-Chairman of the Pakistan Peoples Party (PPP), stated on Thursday that 'some forces' impede ...

EU voices optimism for Bangladesh's election: Calls for democracy, credibility

DHAKA, Bangladesh - The European Union (EU) expressed hope on Wednesday that Bangladesh would hold democratic, credible, peaceful, and participatory ...

Myanmar ethnic group alliance captures trade gate on Chinese border

NAYPYIDAW, Myanmar: Kyar Win, spokesperson for the Myanmar National Democratic Alliance Army, which launched a surprise offensive last month against ...

Thailand will downgrade growth forecast for 2023 to 2.7 percent

BANGKOK, Thailand: This week, Thailand's Deputy Finance Minister Krisada Chinavicharana said after a weaker-than-expected third quarter, the country will downgrade ...