Medtronic has announced the launch of the Prevail drug coated balloon (DCB) catheter in Europe following CE mark. The newest coronary DCB on the market, the Prevail DCB is used during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease (CAD).
During the catheter-based procedure, the balloon inflates within the artery, while the drug is delivered to the arterial tissue where it is absorbed. The Prevail DCB utilises a rapid absorption drug—paclitaxel—to enable treatment of de novo lesions, small vessel disease, and in-stent restenosis (ISR). DCB angioplasty does not require a permanent implant and is often used in cases where the implantation of a drug-eluting stent (DES) is not desirable or is technically challenging.
“As physicians treat more patients with complex lesions, it is critical to have a drug coated balloon that is highly deliverable across a variety of vasculatures, and also utilises a drug that absorbs quickly into the vessel,” said Azeem Latib, lead principal investigator of the PREVAIL Study and section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center, New York, USA. “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.”
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.
In the PREVAIL Study, the Prevail DCB showed exceptional performance in patients with complex lesions, including those with small vessels and those treated for in-stent restenosis, which occurs when a portion of a stented artery is blocked. The Prevail DCB showed favourable late loss (0.05±0.44mm) at six months and a strong safety profile that included no stent thrombosis, target vessel myocardial infarction (TVMI), or cardiac death and low clinically driven target lesion revascularization (6%) out to one year for all patients.
“The launch of the Prevail DCB not only underscores our global leadership and commitment to interventional cardiologists around the world, but also highlights our strong focus on complex PCI,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “We intentionally designed the Prevail DCB to address the challenges posed by smaller, more complex vessels by leveraging our coronary technologies to provide physicians the ability to navigate through tight lesions with greater confidence.”
The Prevail DCB uses PowerTrac, the same technology used in the delivery system for the Medtronic Resolute Onyx DES, to provide superior deliverability and two times more pushability than the previous IN.PACT Falcon technology enabling greater control for tortuous anatomies. In addition, Prevail DCB has a low crossing profile for exceptional crossability.
The Prevail DCB is available for use in Europe and is not approved in the USA.