Medtronic has received US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for its Prevail coronary paclitaxel drug-coated balloon (DCB).
The IDE approval will enable a clinical study of the Prevail DCB for in-stent restenosis (ISR) and de novo small vessel disease.
Medtronic plans to use Prevail Global Clinical Program data to support the DCB approval in the US and Japan.
The multi-centre, dual-cohort clinical trial will recruit up to 1,205 coronary artery disease patients from nearly 65 global centres in the US, Europe, and Asia Pacific.
It includes a randomised controlled evaluation for ISR patients and a single-arm evaluation for de novo small vessel disease patients, focusing on the safety and efficacy of the Prevail DCB.
In the ISR cohort, patients will be randomised 1:1 between the Medtronic Prevail DCB and Boston Scientific’s AGENT DCB to assess non-inferiority.
The de novo small vessel (DNSV) cohort will use historical data from the Resolute Onyx Clinical Program to compare Medtronic’s DCB to drug-eluting stents, the standard of care for small vessel treatment.
The primary endpoint for both cohorts is target lesion failure (TLF) at 12 months, with patient follow-up extending to five years.
The Prevail DCB can be used in percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease.
Medtronic senior vice president and cardiovascular portfolio coronary and renal denervation business and president Jason Weidman said: “The Prevail DCB has the potential to be a significant advancement in the coronary market.
“Medtronic is proud to invest in the expansion of clinical evidence to bring Prevail to patients globally.
“As a leader in drug and device combination therapies for vascular diseases, we look forward to collaborating closely with study investigators and the FDA to initiate patient enrolment in the forthcoming months.”
The Prevail Global Study will leverage Medtronic’s global experience with Prevail DCB, which was launched in Europe in July 2021 for treating de novo lesions, in-stent restenosis, and small vessel disease in coronary arteries.
Currently, the DCB is commercially available in over 79 countries globally.
Recently, the healthcare technology company received FDA approval to conduct an early feasibility study of its Affera Mapping and Ablation System with the Sphere-9 Catheter.
