Medtronic’s Prevail DCB Catheter Launched in Europe

July 26, 2021—Medtronic announced the launch of the Prevail drug-coated balloon (DCB) catheter in Europe following CE Mark approval. The Prevail DCB is used during percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. The Prevail DCB uses paclitaxel to enable treatment of de novo lesions, small vessel disease, and in-stent restenosis.

The company stated that the Prevail DCB features include PowerTrac, the same technology used in the delivery system for the Medtronic Resolute Onyx drug-eluting stent, to provide improved deliverability and more pushability than the previous In.Pact Falcon technology, enabling greater control for tortuous anatomies. Prevail DCB also has a low crossing profile.

Azeem Latib, MD, who is Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York, New York, serves as lead Principal Investigator of the PREVAIL study of the device.

“As physicians treat more patients with complex lesions, it is critical to have a DCB that is highly deliverable across a variety of vasculatures, and also utilizes a drug that absorbs quickly into the vessel,” commented Dr. Latib in the company’s announcement. “The excellent deliverability coupled with a strong safety profile that is backed by clinical evidence makes the Prevail DCB an ideal option for interventional cardiologists using DCB technology to treat their patients.”

According to Medtronic, the Prevail DCB builds on the safety and efficacy demonstrated in the previous-generation In.Pact Falcon DCB clinical program and was reaffirmed by the PREVAIL study presented at the 2020 PCR e-Course conference.

The company reported that in the PREVAIL study, the Prevail DCB showed the following:

• Exceptional performance in patients with complex lesions, including those with small vessels and those treated for in-stent restenosis.
• Favorable late loss (0.05 ± 0.44 mm) at 6 months.
• A strong safety profile with no stent thrombosis, target vessel myocardial infarction, or cardiac death and low clinically driven target lesion revascularization (6%) out to 1 year for all patients.

The Prevail DCB is not available in the United States, advised Medtronic.