Covidien has reported final 12-month results of Determination of Effectiveness of SilverHawk / TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities (DEFINITIVE LE) study.
The multi-centre prospective study enrolled 800 patients with peripheral artery disease (PAD), including claudication, diabetic or non-diabetic critical limb ischemia (CLI), across 47 centres in the US and Europe.
The study assessed the safety and efficacy of directional atherectomy using SilverHawk and TurboHawk devices in treating PAD.
Directional atherectomy is a minimally invasive treatment that removes plaque from the body and restores blood flow in the native artery, according to the company.
The study included pre-specified sub-analysis comparing patency outcomes in diabetic and non-diabetic patients.
Several controls were also included in the study such as Steering Committee oversight, adverse event adjudication by independent physician Clinical Events Committee.
In addition, endpoint analyses of acute angiographic results and duplex ultrasound follow-ups were conducted by two different independent core laboratories.
Universitats-Herzzentrum Freiburg-Bad Kronzingen angiology department head professor Thomas Zeller said the study confirmed equivalent outcomes between diabetics and non-diabetics in terms of patency and persistent clinical improvement up to 12 months after treatment.
"Because diabetics have more advanced PAD, re-stenose faster and are more difficult to treat than non-diabetics, it is critical to preserve future treatment options in this patient population," Zeller added.
"The confirmation from DEFINITIVE LE of directional atherectomy as a treatment modality that provides strong clinical outcomes in diabetics is a welcome and practice-changing finding."
Covidien vascular therapies chief medical officer Mark Turco said, "We are pleased with the long-term results from our groundbreaking DEFINITIVE LE study, which is unique among atherectomy studies conducted to date because of the size of the study and the clinical rigor of execution."
Image: Covidien’s peripheral plaque excision systems removes plaque from the body and restores blood flow in the native artery. Photo: Covidien.