News | Drug-Eluting Balloons | July 07, 2020

World’s First FDA IDE Coronary Patient Treated With a Drug-eluting Balloon

MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting balloon (DEB) for the treatment of in-stent restenosis (ISR). This is the first DEB accepted by the FDA for its breakthrough program. The Selution SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

July 7, 2020 – MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting balloon (DEB) for the treatment of in-stent restenosis (ISR). This is the first DEB accepted by the FDA for its breakthrough program. The Selution SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

The objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy of Selution SLR in treatment of ISR with either drug-eluting or bare metal stents (BMS). The study will support submission for FDA approval. 

“This first patient was treated with the investigational device after suffering a DES ISR. We are delighted to be able to offer our patients this promising new technology”, commented Prof. Pascal Vranckx, Hartcentrum Hasselt, Belgium. “We are excited to participate in a study that validates this novel technology for ISR treatment. SELUTION SLR may provide an additional treatment option for these patients. We very much look forward to the results of this study”.

Up to 418 subjects will be recruited into the study at approximately 60 sites across both the U.S. and Europe.  Subjects need to have a BMS or DES ISR involving a native coronary artery with a reference vessel diameter (RVD) of 2-4.5 mm to qualify for inclusion. Subjects will be randomized to receive either Selution  SLR or standard of care (SOC), a control group with a current DES or a non-drug eluting balloon angioplasty.

The primary endpoint for effectiveness of the study is target lesion failure (TLF), defined as all cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR) at 12 months. 

Subjects will be followed up at one month, six months, 12 months and then annually through five years.

“This is a particularly important study for MedAlliance”, explained Chairman and CEO Jeffrey B. Jump. “No coronary drug-eluting balloon has yet been approved in the U.S., where ISR currently represents 11 percent of all stent implantations. We are excited to introduce this breakthrough technology to help patients around the world”.

The principal investigator of this study is Donald Cutlip, M.D., professor of medicine at Harvard Medical School and chief medical officer at the Baim Institute for Clinical Research. Cutlip helped design the study in consultation with the institute. 

Selution SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained limus release of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon. 

Selution SLR was awarded European CE mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020. It is now is available in Europe and all other countries where the CE mark is recognized. The global market for DEB is estimated to be $2 billion, MedAlliance said.

For more information: http://medalliance.com/


Related Content

News | Balloon Catheter

June 13, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and their subsidiary Arrow ...

Home June 13, 2024
Home
News | Balloon Catheter

April 4, 2024 — The U.S. Food and Drug Administration (FDA) announced that Medos International Sàrl is recalling ...

Home April 04, 2024
Home
News | Balloon Catheter

January 18, 2024 — Summa Therapeutics, LLC announced that the first-in-man injectable angioplasty procedures for ...

Home January 18, 2024
Home
News | Balloon Catheter
Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional ...
Home February 25, 2022
Home
News | Balloon Catheter

February 15, 2022 – CERENOVUS, an emerging leader in neurovascular care and part of Johnson & Johnson Medical Devices ...

Home February 15, 2022
Home
News | Balloon Catheter

May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated ...

Home May 20, 2021
Home
Feature | Balloon Catheter | By Dave Fornell, Editor

The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) ...

Home March 16, 2021
Home
Feature | Balloon Catheter

February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...

Home February 17, 2021
Home
News | Balloon Catheter

June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score ...

Home June 04, 2020
Home
News | Balloon Catheter

February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters — ...

Home February 24, 2020
Home
Subscribe Now