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

Drug Delivery Business

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

MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD

September 24, 2021 By Sean Whooley

MedAlliance SELUTION SLRMedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon.

Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020.

The study will evaluate the safety and efficacy of Selution SLR for treating superficial or popliteal femoral artery lesions in 133 patients across 13 centers in Japan. The prospective, controlled, multicenter, open-label, single-group clinical investigation holds a main variable of primary patency rate at 12 months, with secondary endpoints including major adverse events/revascularization of the treated lesion (RLT), primary patency and change in the Rutherford/ABI/WIQ classification, according to a news release.

“We are extremely satisfied with the quality and normative experience demonstrated by our partner MDK, and particularly proud that Japanese patients can now benefit from our unique technology,” MedAlliance president & CEO Jeffrey B. Jump said in the release. “This is the first sirolimus drug-eluting balloon implanted in Japan, where the current market of paclitaxel-coated balloons generates revenues of more than $ 100 million per year.”

Selution SLR holds CE mark approval for treating peripheral artery disease (PAD) and has received four FDA breakthrough device designations for treating atherosclerotic lesions in innate coronary arteries, coronary in-stent restenosis, peripheral diseases below the knee and indications for arteriovenous fistula.

The platform includes unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.

Last month, the company closed enrollment for a clinical trial for the treatment of patients with disease below the knee. Five days after that, MedAlliance enrolled the first patient in an erectile dysfunction (ED) feasibility study using Selution SLR.

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: MedAlliance

IN CASE YOU MISSED IT

  • FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
  • Medtronic completes Intersect ENT acquisition
  • Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes
  • Here’s what’s next for Insulet after the launch of Omnipod 5, CEO change
  • Senseonics beats The Street in Q1 following Eversense E3 launch

Primary Sidebar

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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
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
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS