• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA grants breakthrough nod to Concept Medical for MagicTouch DCB

May 2, 2019 By Fink Densford

Concept Medical

Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis.

The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company said.

“I was very impressed by the angiographic and IVUS results of MagicTouch in ISR in the Brazil-ISR study. I didn’t encounter any safety or toxicity concerns in the course of the trial,” Dr. Alexandre Abizaid of São Paulo, Brazil’s Institute Dante Pazzanese de Cardiologia said in a prepared statement.

“It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch. MagicTouch has been commercially used in more than 25,000 patients worldwide, with the highest usage in patients in the European region. Besides commercial sales, MagicTouch has been evaluated extensively in clinical studies conducted in countries like the U.K., Italy and Brazil. We are now excited to begin our work with the U.S. FDA in bringing our technology to serve the patients in the USA,” prez & CEO Dr. Manish Doshi said in a prepared release.

“The FDA’s designation of MagicTouch for the Breakthrough Device Program will allow CMI to meet its ambition to provide this promising technology and innovative treatment for ISR patients in the USA. Our confidence in MagicTouch emanates from the positive feedback that we are receiving from the users of our product from current and ongoing commercial sales of MagicTouch in many European countries. CMI is encouraged that the selection of MagicTouch, with its unique drug delivery technology, for the FDA’s Breakthrough Device Program may allow timely access of this promising new technology to the U.S. patients with coronary ISR, with a potential to provide safe and effective treatment,” CMI chairman Dr. Kiran Patel said in a press release.

Last October, Concept Medical said that it received $60 million from cardiologist and serial entrepreneur Dr. Kiran Patel to support pursuit of an FDA investigational device exemption trial for its sirolimus-coated balloon device.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: conceptmedical

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS