Philips’ Stellarex Low-Dose Drug-Coated Balloon Achieves Positive Treatment Results Over a 3-Year Clinical Trial

Image courtesy of Philips.

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Philips, a major global leader in health technology, recently announced the three-year results from both the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical trial. These two trials were part of a series of five trials testing the safety of Stellarex .035″ low-dose DCB to restore and maintain blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to treatment with uncoated balloons, which are currently being used.

The ILLUMENATE Pivotal trial results show that at 36 months, 64.2% of the patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, compared to 51.0% of the patients treated with an uncoated balloon. The patient pool was the most complex studied in a randomized clinical trial. The pool included patients with the highest rates of comorbidities, such as diabetes and renal insufficiency, while 43.9% also had severely calcified lesions.

“The three year data of the ILLUMENATE Pivotal trial and ILLUMENATE EU RCT add to the robust and consistent multi-year data of the Stellarex program,” said S. Jay Mathews, M.D. “The demonstrated durability of Stellarex in the complex patient pool of the ILLUMENATE Pivotal trial, which are patients that are at high risk for restenosis, a recurring blockage, is unique in the industry. Moreover, we continue to see no significant difference in mortality rates between patients treated with Stellarex and those treated with uncoated balloons, which confirms our confidence in the safety profile of Stellarex.”

According to iData Research, similar to other medical device markets, the interventional cardiology market has been experiencing a period of consolidation in recent years. Large competitors are either entering the overall market or expanding their reach by entering new segments through strategic mergers and acquisitions. One trend that has risen as a result of consolidation is the bundling of devices at a discount. Bundling is driven by unfavorable reimbursement conditions and larger competitors, who have a wide variety of devices to offer across the interventional cardiology market and are able to negotiate more cost-effective contracts with hospitals and labs. As a result, competitive pressure is expected to contribute to declines in prices across the majority of segments in the market. Seeing as Philips is successful main player in many market segments, this should offset the downward market pressure.


For Further Information

More on the interventional cardiology market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Interventional Cardiology 



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