News | Drug-Eluting Balloons | October 15, 2019

Philips Introduces New 200mm and 150mm Stellarex 0.035-inch Low-dose Drug-coated Balloons

Stellarex’s coating enables a low therapeutic drug dose and has demonstrated a significant treatment effect and high safety profile among peripheral artery disease patients

Philips Introduces New 200mm and 150mm Stellarex 0.035-inch Low-dose Drug-coated Balloons

October 15, 2019 — Royal Philips introduced two new balloons to its Stellarex 0.035-inch low-dose drug-coated balloon (DCB) portfolio. The new 200mm and 150mm Stellarex 0.035-inch low-dose DCBs have received approval from the U.S. Food and Drug Administration (FDA) for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries, both arteries in the upper leg. The new balloons broaden physicians’ treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis. The 200mm and 150mm Stellarex 0.035-inch low-dose DCBs are now available in the U.S. and will be rolled out to other markets in due course.

PAD affects more than 200 million people worldwide [1]. If left untreated, it can result in critical limb ischemia (CLI), and 34 percent of patients with CLI undergo amputation within one year of diagnosis. Broadening physicians’ treatment options helps ensure more PAD patients will receive treatment before the disease progresses.

All Philips’ Stellarex DCBs feature EnduraCoat technology, a coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it. The coating provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose. The Stellarex balloon is now available in 40, 60, 80, 100, 120, 150 and 200mm lengths for the treatment of lesions in the superficial femoral and popliteal arteries with vessel diameters of 4-6mm.

The results of third-party analyses of patient-level data from worldwide clinical trials of the Philips Stellarex 0.035-inch low-dose DCB in lengths under 150mm were recently published in Circulation, a peer-reviewed journal of the American Heart Association.[2] Primary safety analysis of Philips Stellarex DCB three-year data, comprising a large published, pooled set of randomized controlled trial (RCT) data for a single paclitaxel-based device, showed no difference in mortality between patients treated with the Philips Stellarex DCB and those treated with percutaneous angioplasty, the current standard of care. The analyses represent one of the industry’s most extensive and rigorous safety assessments of a paclitaxel-based device.

For more information: www.usa.philips.com/healthcare

 

Reference  

1. Shu J., Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis, published online May 22, 2018. doi: 10.1016/j.atherosclerosis.2018.05.033

2. Gray W.A., Jaff M.R., Parikh S.A., et al. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation, published online Sept. 30, 2019. https://doi.org/10.1161/CIRCULATIONAHA.119.040518


Related Content

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now