|Covidien is studying whether its SilverHawk device can be effective as part of a combination therapy for peripheral artery disease--courtesy of Covidien.|
Covidien ($COV) wants to see if its plaque-removing devices can help ward off arterial narrowing in patients with peripheral artery disease, and the company has completed enrollment in a multicenter study that could eventually support an expanded indication for the tech.
The company is testing out a combination therapy, starting with arterial plaque removal through the SilverHawk or TurboHawk devices and following up with a drug-coated balloon. The European study, dubbed DEFINITIVE AR, will test to see if pretreating PAD patients with Covidien's devices can prevent a narrowing of the arteries and reduce the need for repeat procedures. A control group will receive just the balloon treatment.
Researcher Gunnar Tepe of Klinikum Rosenheim in Germany said the plaque-removing process--called directional atherectomy--could bolster drug delivery and make for a more effective PAD treatment.
"The ability of a drug-coated balloon to prevent restenosis may be diminished by the amount and type of plaque build-up in a patient's vessel," Tepe said in a statement. "Removing plaque with directional atherectomy prior to treatment with a drug-coated balloon may enhance durability of outcomes through increased drug penetration and uptake into smooth muscle cells."
For Covidien, the yearlong study presents an opportunity to stretch its devices' reach. Other plaque-fighting treatments work by compressing the artery-clogging material, while TurboHawk and SilverHawk actually remove it, which makes the devices ideal for treating complex PAD, Mark Turco, the company's vascular CMO, said in a statement.
"We are eager to see the results of DEFINITIVE AR and to understand if this combination therapy of debulking followed by anti-restenotic therapy could lead to improved drug delivery and improved patient outcomes," Turco said.
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