Have CE mark, will travel. After receiving regulatory clearance in Europe, Medtronic’s newest drug-coated balloon catheter has begun its commercial launch on the continent.
The Prevail device—which has yet to be cleared by the FDA in the U.S.—is designed to treat symptoms of coronary artery disease in cases where the more common drug-eluting stent either won’t work or would be difficult to implant in the arteries that carry blood to the heart.
In those cases, the catheter is inserted into a narrowed or blocked coronary artery. Once there, the balloon inflates to fill the blood vessel and delivers a chemotherapy drug directly to the arterial tissue to treat lesions, small vessel disease and in-stent restenosis caused by coronary artery disease.
The Prevail DCB is coated in a mixture of the chemotherapy treatment paclitaxel and urea, which serves as an inactive molecular vehicle to deliver the drug to the artery within 30 to 60 seconds.
Compared to drug-eluting stents, which are typically implanted in patients for several years, Medtronic’s drug-coated balloon catheter is inserted only until the fast-absorbing dose of paclitaxel has been transferred to the artery wall.
In Medtronic’s study of its latest drug-coated balloon catheter’s ability to treat coronary artery blockages, the diameter of 50 patients’ treated arteries had narrowed by an average of just 0.05 millimeters after six months.
Additionally, after one year, none of the participants in the study had experienced stent thrombosis, target vessel myocardial infarction or cardiac death. In that time span, only about 6% saw revascularization of their targeted lesions.
The Prevail DCB represents an upgrade to Medtronic’s In.Pact Falcon catheter, which was cleared to treat coronary artery disease in Europe more than a decade ago. The Prevail device is designed to be easier to navigate through narrowed or blocked arteries, with nearly twice the “pushability” of the In.Pact Falcon.
“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,” said Jason Weidman, senior vice president and president of the Medtronic’s coronary and renal denervation business.
Though the FDA has yet to approve the Prevail or any other drug-coated balloon to treat coronary artery disease in the U.S., several balloon catheters from Medtronic and other medtech developers have gotten the green light to treat patients with peripheral artery disease—in which the arteries that carry blood away from the heart to the rest of the body are narrowed or blocked due to fat and calcium buildups in the arterial walls.
Medtronic’s In.Pact Admiral device, for one, received premarket approval from the FDA in 2014 to treat peripheral artery disease in the upper leg. And just last fall, Boston Scientific’s own paclitaxel-coated Ranger catheter snagged an FDA OK to be used in the leg’s femoral and popliteal arteries.