Covidien has reported final 12-month results from Determination of Effectiveness of SilverHawk / TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities (DEFINITIVE LE ) trial.
The multi-center, prospective study, which has enrolled 800 patients with peripheral artery disease, including claudication, diabetic or non-diabetic, critical limb ischemia (CLI), has assessed the safety and efficacy of directional atherectomy using SilverHawk and TurboHawk devices in treating PAD.
The company said directional atherectomy is a minimally invasive treatment that removes plaque from the body and restores blood flow in the native artery.
The study included a 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 an independent physician Clinical Events Committee.
In addition, endpoint analyses of acute angiographic results and duplex ultrasound follow-up 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."