Flexible Stenting Solutions (FSS) has enrolled first patients for its Japan FlexStent clinical trial and the US FlexStent Open trial in Belgium.
The multi-center, prospective, randomized Japan FlexStent trial is designed to compare the FlexStent with a plain old balloon angioplasty.
The prinicipal investigator for the Japan FlexStent trial is Kishiwada Tokushukai Hospital Cardiovascular Center director Yoshiaki Yokoi.
FSS’ partner Goodman who executed and supported the trial will enroll 100 patients and the design includes 5, 6, 7 and 8 mm diameters and lengths of 30-200 mm.
Imelda Hospital’s Patrick Peeters and A Z Sint-Blasius Hospital’s Marc Bosiers have enrolled first patients for US Open FlexStent trials’ two European sites.
A Z Sint-Blasius Hospital Marc Bosiers said during their first case with the FlexStent they implanted a 6x60mm stent in a short SFA occlusion and the final angiographic control showed excellent wall apposition of this stent design.
"We definitely look forward to tackling longer, more challenging lesions and to see how this novel device will behave on longer term," Bosiers said.
The company hopes that the next generation femoropopliteal stent and delivery system it can improve patient care in the high growth peripheral vascular segment.