Medtronic has introduced its Prevail drug coated balloon (DCB) catheter in Europe for the treatment of coronary artery disease (CAD) patients.
The development comes after the company received CE mark for the device.
Prevail DCB is indicated for use in percutaneous coronary intervention (PCI) procedures to treat constricted or hindered coronary arteries in CAD patients.
It leverages PowerTrac technology to offer improved deliverability and two times more pushability compared to the company’s IN.PACT Falcon technology, providing increased control for complex anatomies.
Furthermore, the device features enhanced crossability with a low crossing profile, Medtronic noted.
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In a catheter-based procedure, Prevail’s balloon inflates within the artery and the drug is carried to the arterial tissue where it gets absorbed.
The DCB uses a quick absorption drug, paclitaxel, to aid in treating de novo lesions, small vessel disease and in-stent restenosis (ISR).
In addition, DCB angioplasty does not need a permanent implant, so is used when implanting a drug-eluting stent (DES) is unsuitable or technically unfeasible.
Medtronic coronary and renal denervation business senior vice-president and president Jason Weidman said: “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.
“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.”
In the PREVAIL Study, the DCB demonstrated greater performance in patients with complex lesions, such as those with small vessels and those treated for ISR, which arises when part of a stented artery is obstructed.
Furthermore, the device had a robust safety profile, including no stent thrombosis, target vessel myocardial infarction, cardiac death and reduced clinically-driven target lesion revascularisation for a year in all subjects.
Prevail DCB also showed a beneficial late loss (0.05 ± 0.44mm) at six months.
Last month, Medtronic obtained expanded approval from the US Food and Drug Administration for its Arctic Front Family of Cardiac Cryoablation Catheters to treat recurrent symptomatic paroxysmal atrial fibrillation.