Clinical trial results from MASCOT Trial evaluating AngioSculpt PTA Scoring Balloon Catheter announced

AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today favorable clinical trial results from the MASCOT Trial, an important study evaluating the AngioSculpt® PTA Scoring Balloon Catheter for the treatment of femoro-popliteal PAD (peripheral artery disease).

“Sales of AngioSculpt devices for the treatment of PAD have been growing rapidly, and this important new clinical data provides physicians worldwide with further confirmation of its usefulness and effectiveness.”

MASCOT (ClinicalTrials.gov NCT 00619788) was a prospective non-randomized European multi-center trial investigating the role of the AngioSculpt PTA Scoring Balloon Catheter for the treatment of severe femoro-popliteal stenotic disease (≤ 8 cm in length). Patients with debilitating claudication (severe leg pain on walking) were treated at three pre-eminent European clinical sites with the recently introduced larger and longer AngioSculpt devices. Primary endpoints included safety at 30 days (complication-free survival) and target lesion patency at 12 months, as determined by Duplex ultrasound.

The study results demonstrated an excellent safety outcome, with 96% of patients complication-free at 30 days, and a very favorable overall target lesion patency rate of 74.1% at 12 months. The study was conducted at two sites in Belgium and one site in Germany.

“The promising results from MASCOT suggest that it may be possible to avoid stenting in a significant proportion of patients with shorter lesions involving the SFA (superficial femoral artery) when using the AngioSculpt as primary therapy,” said Patrick Peeters, M.D., Principal Investigator for the MASCOT Trial.

“MASCOT is the first study documenting the outcome of patients with severe SFA and popliteal disease treated with the AngioSculpt,” said Gary Gershony, M.D., AngioScore’s Chief Medical Officer. “We are very gratified by the excellent acute and long-term clinical results experienced by patients in this study. The data strongly suggest that in patients with severe SFA disease (≤ 8 cm in length) who are successfully treated with the AngioSculpt, adjunctive stenting should not be necessary.”

“We are very encouraged by the positive clinical data from MASCOT,” said Thomas R. Trotter, President and CEO of AngioScore. “Sales of AngioSculpt devices for the treatment of PAD have been growing rapidly, and this important new clinical data provides physicians worldwide with further confirmation of its usefulness and effectiveness.”

“PAD is one of the fastest-growing segments of the Endovascular Market, with an estimated two million annual procedures worldwide. In addition, longer AngioSculpt devices (≥ 10 cm) currently in development have the potential of extending the usefulness of this technology to patients with even more diffuse SFA disease.”

The AngioSculpt® Scoring Balloon Catheter represents the next generation in angioplasty catheters. Its innovative nitinol scoring element provides unique anti-slipping properties while circumferentially dilating plaque, providing a precise and predictable dilatation across a wide range of lesion types. The AngioSculpt provides the versatility and effectiveness of a new technology together with the simplicity and deliverability of a high-performance balloon catheter.

SOURCE AngioScore, Inc.