AngioScore, a developer of angioplasty catheters for use in the treatment of cardiovascular disease, has presented favorable clinical trial results from the Mascot Trial, a study evaluating the AngioSculpt PTA Scoring Balloon Catheter for the treatment of femoro-popliteal PAD (peripheral artery disease).
Mascot trial was a prospective non-randomised 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.
In the study, the 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 have demonstrated a 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 AngioSculpt Scoring Balloon Catheter represents the next generation in angioplasty catheters. Its nitinol scoring element provides anti-slipping properties while circumferentially dilating plaque, provides 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.
Patrick Peeters, principal investigator of Mascot Trial, said: “The promising results from Mascot suggest that it may be possible to avoid stenting in a proportion of patients with shorter lesions involving the SFA (superficial femoral artery) when using the AngioSculpt as primary therapy.”
Gary Gershony, chief medical officer of AngioScore, said: “Mascot is the first study documenting the outcome of patients with severe SFA and popliteal disease treated with the AngioSculpt. We are gratified by the 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.”
Thomas Trotter, president and CEO of AngioScore, said: “We are encouraged by the positive clinical data from Mascot. 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.”