DEFINITIVE AR pilot study: Combining DEB with the TurboHawk device
Published date : 27 April 2010
Article date : 27 April 2010
ev3 recently announced the launch of the TurboHawk system for use in all plaque morphologies, including calcified lesions. Based on their SilverHawk peripheral plaque excision system, which was originally cleared for use by the FDA in 2003, the TurboHawk incorporates changes in the geometry and material of the cutter structure to treat calcified lesions that may be resistant to conventional treatment.
According to the company, the TurboHawk features a cutter blade with four angled breakers for added performance when addressing all plaque morphologies, a catheter jog to provide consistent cutter apposition force, and a newly designed drive shaft to improve cutting efficiency. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.
DEFINITIVE AR study
Medrad Interventional/Possis announced the initiation of a supply agreement with ev3 for Medrad to provide its Cotavance peripheral drug-eluting balloon (DEB) angioplasty catheter with Paccocath drug technology for study in combination with ev3’s SilverHawk and TurboHawk plaque excision systems in the DEFINITIVE AR European pilot study for treating lower extremity peripheral arterial disease.
The DEFINITIVE AR study is a prospective, multi-centre, randomised pilot study evaluating the use of either the TurboHawk or SilverHawk systems followed by treatment with the Cotavance drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease. The pilot study will evaluate up to 125 patients in Europe and is anticipated to begin in the second half of 2010. The companies anticipate that a global, multi-centre, pivotal trial will follow the completion of the pilot study. Professor Thomas Zeller, MD, and Professor Gunnar Tepe, MD, will lead the study.
According to Tepe, “Drug-eluting balloons with Paccocath technology demonstrated encouraging safety and efficacy results in the THUNDER and FemPac trials. However, I believe that treatment outcomes could be improved by first removing plaque from the vessel with plaque excision prior to using a drug-coated balloon. The combination of TurboHawk or SilverHawk plaque excision followed by the use of the Cotavance balloon catheter may allow for enhanced drug uptake and an improved acute result and durability in the treated vessel.”
