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| OrbusNeich's Combo dual-therapy stent (click to enlarge)--Courtesy of OrbusNeich |
OrbusNeich said it has wrapped up enrollment in a 1,000 patient post-marketing registry to evaluate its innovative Combo dual-therapy stent in real-world conditions over the next few years.
The Hong Kong medical device maker said it completed enrollment in what is known as the REMEDEE Registry, which is designed to evaluate Combo during routine use and care at centers in France, Latvia, Luxembourg, The Netherlands, United Kingdom and Spain.
Combo relies on drug-eluting and endothelial progenitor cell capture (EPC) stent technology. The drug-eluting portion comes from a biodegradable polymer that dissipates in 90 days, according to the company. And the EPC tech promotes accelerated natural healing through promotion of endothelial coverage of the vessel wall after a stent implant. Combo is CE marked in Europe, but not available in the U.S. or Japan, though OrbusNeich recently began a U.S.-Japan proof-of-concept study for Combo, that will enroll 572 patients at more than 50 sites.
The REMEDEE Registry will evaluate Combo's long-term safety and performance, and primary endpoint data is due by the 2015 second quarter.
Cardiac stents are ubiquitous in the developed world, and innovations such as this (bioresorbable stents are another advance pursued by some) could help jump-start a sector that has long been stagnant. Post-marketing data is also crucial, as it could aide OrbusNeich's U.S. and Japanese regulatory approval efforts. Post-marketing trials, if successful, offer evidence to regulators in markets where a device isn't approved for use that it is safe and viable. They also can assist marketing efforts in regions where a device is approved (the more evidence that a product works, the better). Additionally, a post-marketing trial or registry can uncover potential problems by studying the wider use of a device.
OrbusNeich, which is based in Hong Kong, also has operations in the Netherlands, China and Florida in the U.S.
- read the release