Jan 23, 2019

Philips releases latest data reinforcing the safety profile of its Stellarex low-dose Drug-Coated Balloon

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the release of the latest pooled analysis of patient-level data of over 2,300 patients treated with Philips’ Stellarex Drug-Coated Balloon (DCB) in above-the-knee (ATK) studies, which reinforces the strong safety profile of Stellarex. The independent, third party pooled analysis demonstrated low mortality rates through three years after the treatment with no device-related deaths.

Sean Lyden, MD and Chairman of the Department of Vascular Surgery, Cleveland Clinic (US), presented the data at the ‘Long-term safety of drug-eluting technologies in the leg – recent findings, controversies and future outlook’ symposium at the 2019 Leipzig Interventional Course (LINC) in Leipzig, Germany.

In this video, Sean Lyden and Fabrizio Fanelli (Rome, Italy) discuss the safety and future of drug-coated balloons (DCB) in light of the latest pooled analysis of patient-level data.

“The LINC session provided important new patient-level data regarding mortality in patients with peripheral arterial disease receiving paclitaxel devices – stents or DCBs – to restore and maintain blood flow in the superficial femoral and popliteal arteries in their legs,” said William Gray, MD, FACC, FSCAI, and President of the Lankenau Heart Institute and investigator for the Stellarex clinical trials. “The data from the Stellarex clinical trial programs was strong, and represented over 2,300 patients. When the three-year-outcomes were examined, there were no cardiovascular or non-cardiovascular mortality differences between the groups treated with Stellarex and the control arm. This is very reassuring, and this patient-level data will be amalgamated with other paclitaxel device data in order to complete the analysis. These efforts are already underway, as is a publication specifically regarding these Stellarex results.”

Based on this latest patient-level analysis, we remain confident in the safety and performance of our unique Stellarex low-dose Drug-Coated Balloon.

Chris Barys

Business Leader, Image Guided Therapy Devices at Philips

“Based on this latest patient-level analysis, we remain confident in the safety and performance of our unique Stellarex low-dose Drug-Coated Balloon,” said Chris Barys, Business Leader, Image Guided Therapy Devices at Philips. ”We will continue to communicate any relevant findings we obtain, to ensure our physicians have the most current information on our technologies for optimal treatment of their patients.”

Philips’ image-guided therapy solutions include interventional imaging systems, smart devices, software and services that enable clinicians to decide, guide, treat and confirm the appropriate cardiac and peripheral vascular treatment. By designing intelligent technologies and services that help clinicians to deliver a consistent standard of care, optimize care pathways and integrate workflows, Philips is enabling better patient and population outcomes.

The Stellarex DCB is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease and is FDA approved and CE Marked in the US and Europe.

Philips is part of a pan-industry effort to independently analyze and report all patient-level safety data associated with paclitaxel-eluting devices for the treatment of peripheral artery disease above the knee. The effort is led by VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research.

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2017 sales of EUR 17.8 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.