MedPath

Medtronic's Prevail DCB Receives FDA IDE Approval for Pivotal Clinical Trial

• Medtronic has secured FDA IDE approval to initiate a pivotal clinical trial for its Prevail drug-coated balloon (DCB). • The trial will evaluate the Prevail DCB for treating in-stent restenosis (ISR) and de novo small vessel disease. • The study will enroll 1,205 patients across the US, Europe, and Asia Pacific, with a primary endpoint of target lesion failure at 12 months. • The trial aims to support the approval of Prevail DCB in the US and Japan, offering an anti-restenotic solution without permanent stenting.

Medtronic has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial for its Prevail coronary paclitaxel drug-coated balloon (DCB). The trial will assess the device's effectiveness in treating in-stent restenosis (ISR) and de novo small vessel disease. The dual cohort, international, multi-center clinical trial plans to enroll up to 1,205 subjects with coronary artery disease from approximately 65 centers across the US, Europe, and Asia Pacific.

Trial Design and Objectives

The Prevail Global Clinical Program aims to gather data supporting the product’s approval in the US and Japan. The trial includes a randomized controlled ISR patient evaluation and a single-arm assessment of de novo small vessel disease patients to determine the efficacy and safety of the Prevail DCB.

Study Leadership and Cohort Details

Dr. David Kandzari and Professor Bruno Scheller from Saarland University, Germany, will lead the ISR Cohort. This cohort will compare the Medtronic Prevail DCB with Boston Scientific’s AGENT DCB in a 1:1 ratio to evaluate non-inferiority. Azeem Latib, system director of Interventional Cardiology at Montefiore Health System, and Darren Mylotte, consultant cardiologist at Galway University Hospital, will oversee the DNSV Cohort. This cohort will compare the Prevail DCB against drug-eluting stents using historical control data from the Resolute Onyx Clinical Program.

Endpoints and Follow-Up

For both cohorts, the primary endpoint will be target lesion failure (TLF) at 12 months, with patient follow-up extending to five years. Target lesion failure is a composite endpoint that typically includes cardiac death, target vessel myocardial infarction, and target lesion revascularization.

Clinical Significance

According to Prevail Global Study co-principal investigator David Kandzari, drug-coated balloons provide clinicians with an anti-restenosis solution without the need for a permanent stent, which is particularly important as physicians treat more patients with complex lesions. The Prevail DCB is designed for use during percutaneous coronary intervention procedures to treat narrowed or blocked arteries in patients with coronary artery disease. During this procedure, the balloon inflates within the artery while delivering the paclitaxel drug to the arterial tissue, where it is absorbed to provide a lasting anti-restenotic effect. The global study builds on experience with Prevail DCB usage worldwide.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

NextBioMedical's Nexsphere-F Receives FDA IDE Approval for Knee Osteoarthritis Trial

NextBioMedical's Nexsphere-F has received FDA IDE approval for a clinical trial (RESORB) to treat knee osteoarthritis via genicular artery embolization (GAE).
The RESORB trial is a multi-center, randomized, open-label study evaluating Nexsphere-F's efficacy in alleviating pain and improving mobility in OA patients.

RapidPulse's Cyclic Aspiration System Receives FDA Approval for Ischemic Stroke IDE Study

RapidPulse has received FDA approval to begin an Investigational Device Exemption (IDE) study for its cyclic aspiration system in acute ischemic stroke (AIS).
The IDE study will enroll patients in the U.S. and Europe in 2025 to evaluate the safety and efficacy of RapidPulse's pulsed aspiration method.

FDA Approves R3 Vascular's IDE for ELITE-BTK Trial of Magnitude Scaffold in PAD

R3 Vascular received FDA IDE approval to begin the ELITE-BTK pivotal trial, evaluating the Magnitude drug-eluting bioresorbable scaffold for below-the-knee PAD.
The Magnitude scaffold, made from a unique polylactic acid polymer and coated with sirolimus, aims to improve outcomes in chronic limb-threatening ischemia (CLTI) patients.

R3 Vascular's MAGNITUDE Scaffold Receives FDA Approval for BTK PAD Trial

The FDA has approved R3 Vascular to begin the ELITE-BTK trial for its MAGNITUDE drug-eluting bioresorbable scaffold, targeting below-the-knee peripheral arterial disease.
The MAGNITUDE scaffold, made from ultra-high molecular weight polylactic acid polymer, is designed to gradually absorb into the tissue while providing structural support.

Medtronic's Prevail Drug-Coated Balloon Receives FDA IDE Approval for Pivotal Trial

Medtronic has received FDA approval for an IDE to begin a pivotal clinical trial of its Prevail drug-coated balloon (DCB).
The trial will evaluate the safety and efficacy of Prevail DCB for in-stent restenosis (ISR) and de novo small vessel disease.

FDA Approves Biotronik's Selectra 3D Catheter and Solia S Lead for Left Bundle Branch Area Pacing

The FDA has granted approval for Biotronik's Selectra 3D catheter, used with the Solia S lead, for left bundle branch area pacing (LBBAP).
This marks the first FDA-approved stylet-driven lead and dedicated delivery catheter system for LBBAP, offering a new option for cardiac pacing.

FDA Approves Biotronik's Left Bundle Branch Area Pacing System

The FDA has granted approval for Biotronik's Selectra 3D catheter and Solia S lead system for left bundle branch area pacing (LBBAP).
The approval was based on the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate.

FDA Grants Breakthrough Therapy Designation to OAC Therapy for Myotonic Dystrophy Type 1

The FDA has awarded Breakthrough Therapy Designation to Avidity Biosciences' AOC therapy, delpacibart etedesiran, for treating myotonic dystrophy type 1, highlighting its potential as an effective treatment for this rare muscle disease. The therapy, which targets the root cause of DM1 by reducing DMPK mRNA, has also received Orphan Drug and Fast Track designations. Avidity Biosciences plans to initiate a global Phase 3 HARBOR study in 2024, following positive long-term data from the phase 2 MARINA-OLE trial.

U.S. FDA Grants Priority Review for Elafibranor, a Potential New Treatment for Primary Biliary Cholangitis

The U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) of elafibranor, a potential novel second-line treatment for primary biliary cholangitis (PBC), a rare cholestatic liver disease. The European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have also validated the Marketing Authorization Application (MAA) for review. The target FDA PDUFA date is set for June 10, 2024.

Concept Medical's MagicTouch Sirolimus-Coated Balloon Receives FDA IDE Approval for Small Vessel Coronary Disease

Concept Medical's MagicTouch SCB receives FDA IDE approval for treating small vessel coronary disease, marking the third IDE approval for the device family.
The approval allows Concept Medical to begin a pivotal clinical study to assess the safety and efficacy of MagicTouch SCB in small vessel coronary disease.

Reference News

[1]
Medtronic's Prevail DCB pivotal trial receives FDA IDE approval - Medical Device Network
medicaldevice-network.com · Oct 24, 2024

Medtronic received FDA IDE approval for a pivotal trial of its Prevail coronary paclitaxel drug-coated balloon (DCB) to ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy