QT Vascular's Chocolate Heart DCB Shows Promise in FIH Study

January 7, 2016—QT Vascular Ltd. announced the initial acute and 30-day outcomes from the first-in-human (FIH) study of the Chocolate Heart drug-coated balloon in a group of 19 patients with de novo coronary disease. The Chocolate Heart drug-coated balloon demonstrated promising early results with an overall rate of major adverse coronary events of 0% at 30 days. Additionally, procedural outcomes demonstrated the incidence of bailout stent placement, significant dissection, abrupt closure, and subacute occlusion was 0%.

The Chocolate Heart first-in-human study is a single-center feasibility study conducted at CECANOT Hospital in Santo Domingo, Dominican Republic for up to 30 patients with symptomatic, de novo coronary disease. The primary endpoint is target lesion late lumen loss at 6 months (to be assessed by the independent angiographic core lab at Yale University in New Haven, Connecticut). Secondary endpoints include device, lesion, and procedural success, abrupt closure, threatened closure, and the crossover rate to stenting caused by unsuccessful angioplasty. Patients will also undergo intravascular ultrasound assessment at 6 months (reviewed by the independent intravascular ultrasound core lab at Cardiovascular Research Center in Sao Paolo, Brazil).

Jihad Mustapha, MD, of Metro Hospital in Wyoming, Michigan, presented the 30-day results at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which was held October 11–15 in San Francisco, California.

The company also noted that at 6-month follow-up, the core-lab adjudicated average late lumen loss in the first 15 patients was only 0.02 mm. Consistent with this low average late lumen loss, only a single patient required an additional procedure at the treated site.

In the company’s press release, Prof. Bruno Scheller, MD, of the University of Saarland in Homburg/Saar, Germany, commented, “While this is an early feasibility study and larger confirmatory studies will be needed, these preliminary results are very encouraging as they hint at the possibility of being able to offer an effective treatment to patients with de novo coronary disease without the use of a permanent implant, such as a metallic stent or a bioresorbable scaffold, which may take years to dissolve. The gentle dilatation of the Chocolate platform may account for these excellent early outcomes. I am looking forward to seeing the mid- and long-term outcomes with this unique device.”

In July 2015, European CE Mark was approved for the QT Vascular Chocolate Touch drug-coated peripheral balloon, which will be launched commercially in countries recognizing CE Mark early this year. The Chocolate Touch is not approved for use in the United States, advised the company.