TriReme Medical, a subsidiary of QT Vascular, has announced the enrollment of first three patients in its single arm, drug-coated Chocolate PTA balloon clinical study.
Auckland City Hospital, New Zealand, Interventional Services director Dr Andrew Holden, the co-principal investigator of the drug-coated Chocolate PTA balloon clinical study, has performed these procedures.
The single arm study has been designed to assess the rate of procedural success immediately after treatment as well as persistence of positive outcomes at six and 12 months post procedure. Independent core laboratories will evaluate all key outcomes of the trial.
The study will enroll a minimum of 30 patients at up to four centers in New Zealand and Germany.
TriReme Medical has developed the drug-coated Chocolate PTA balloon to treat peripheral arterial disease patients. The PTA balloon combines the acute benefits of the US Food and Drug Administration and CE approved Chocolate PTA balloon with paclitaxel-based coating.
Paclitaxel-based coating is an anti-proliferative drug proven to reduce the build-up of tissue in the vessel that can occur months after the original procedure. The underlying Chocolate PTA balloon platform has showed a very low rate of dissections and bail out stenting in clinical studies.
TriReme Medical president and CEO Dr Eitan Konstantino noted first generation drug-coated balloons are based on plain old balloon angioplasty (POBA) technology that goes back more than 30 years.
"POBA is well known to induce significant vessel trauma and often requires adjunctive stenting to complete the procedure.
"The mere addition of a drug does not solve this issue. The drug coated Chocolate® PTA balloon is the only product that is designed to address both the acute trauma and long term results," Dr Konstantino added.