World's First FDA IDE Coronary Patient Treated With a DEB

▴ worlds-first-fda-ide-coronary-breakthrough-medalliance
Up to 418 subjects will be recruited into the study at approximately 60 sites across both the US and Europe

MedAlliance has announced enrollment of the first patient in its study of SELUTION SLR 014 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 drugs, 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 the treatment of ISR with either drug-eluting or bare-metal stents (BMS). The study will support the 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 Professor 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 US and Europe. Subjects need to have a BMS or DES ISR involving a native coronary artery with a reference vessel diameter (RVD) of 2.00 – 4.50 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 the 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 US, where ISR currently represents 11% 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, Professor of Medicine at Harvard Medical School and Chief Medical Officer at the Baim Institute for Clinical Research. Professor 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 (SLR) 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 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.

Tags : #Medalliance #FDA #PeripheralArteryDisease #BMS #ISRTreatment #SustainedLimusRelease #PharmaNews

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Sexual wellness superstore, Love Depot launches digital campaign to deliver every desireMarch 28, 2024
Recharge Your Life: Simple Ways to Boost Your Physical and Mental EnergyMarch 28, 2024
The Neurological Toll of Common Household Chemicals: Insights from Recent ResearchMarch 28, 2024
The Aging Puzzle: Decoding the Mechanisms of AgingMarch 28, 2024
The Double-Edged Sword of Kala-azar Treatment: Shedding Light on Eye ComplicationsMarch 28, 2024
FTCCI Launches Industry-Academia Connect to improve the employability of Engineering Graduates and address the growing demand for Talent in Emerging TechMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
2nd Edition of IIFL JITO Ahimsa Run for peace & for non-violence to be held on 31st MarchMarch 27, 2024
Brij Hotels Announced 4 Million in Series A Funding March 27, 2024
Combatting Childhood Sedentariness: The Key to Preventing Premature Vascular DamageMarch 27, 2024
Crucial Findings: Unlocking Paths to Combat Ebola's DevastationMarch 27, 2024
Guarding Against Disease: The Crucial Role of Oral Hygiene in Preventive HealthcareMarch 27, 2024
Sanofi & Cipla announce exclusive distribution partnership to expand reach of CNS portfolio in IndiaMarch 26, 2024
Surmandal's Tribute to the Legends of Hindustani Classical MusicMarch 26, 2024
In Moscow, over 350,000 mammograms have been analyzed using artificial intelligence as part of the compulsory health insurance programMarch 26, 2024
Embark on a Creative Journey: "Kala For A Cause" Unveils Pottery Workshop Series March 26, 2024
Healthtech pioneer Aurora Innovation appoints new CEO – expands in Europe with service that streamlines patient-healthcare interactionMarch 26, 2024
In A Rare Feat, 45 YO Woman Walks Within 6 Hrs. Of Dual Robotic Surgery In A Single Operation At HCGMCCMarch 26, 2024
Improve Cancer Care through Automated CT Analysis: Oncoshield – CTMarch 26, 2024