The approval was for both de novo and restenotic lesions in upper leg arteries.
The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to the Stellarex DCB portfolio to broaden options for treating peripheral artery disease in patients with a high risk of restenosis in the superficial femoral or popliteal arteries.
Royal Philips’ Stellarex DCBs include EnduraCoat, a coating made up of polyethylene glycol excipient with amorphous and crystalline paclitaxel particles designed to enable a low dosage. The balloons are available at lengths of 40, 60, 80, 100, 120, 150 and 200mm for the treatment of lesions in arteries with vessel diameters of 4–6 mm.
Earlier this month, Royal Philips touted data on the Stellarex balloons from a pivotal trial and a European randomized controlled trial, which altogether included 589 patients. Results showed that 2.3% of patients in the pivotal study and 3.7% in the E.U .RCT were lost to follow-up within the three years of the study.
Additional analysis included four Stellarex single-arm studies, which included 2,495 patients with peripheral artery disease, of which 2,325 were treated with Stellarex. The primary safety analysis showed no difference in mortality between Stellarex patients and patients treated with the standard uncoated PTA, while it also highlighted zero device-related deaths and no correlation of Stellarex to late all-case mortality.
The Stellarex DCB won FDA pre-market approval in June 2017. The new balloons are now available in the U.S. and Royal Philips said they will be brought to other markets in due time.
“With its unique coating, Stellarex is unlike any other DCB in the industry for the treatment of PAD,” GM of image-guided therapy devices Chris Landon said in a news release. “Stellarex is the only low-dose drug-coated balloon with a proven treatment effect at three years compared to the existing standard of care in the U.S. and Europe. By expanding our range of Stellarex balloons, we are adding to the treatment options that physicians can use to provide optimal care for each patient with peripheral arterial disease.”
Shares of PHG were down –0.2% at $43.10 per share in midday trading today.