The sirolimus-eluting device is made using a tyrosine-derived polymer that is visible under x-ray. Data from Reva’s Fantom II clinical trial found that the device resulted in a 4.2% rate of major adverse cardiac events after 12 months and 5.6% after 24 months.
“Fantom is new-generation BRS technology offering the novel Tyrocore polymer, thin struts, and visibility under x-ray angiography,” Dr. Bernardo Cortese, who performed the implantation at the Fatebenefratelli Hospital in Milan, said in prepared remarks. “During the procedure, I was able to experience first-hand the benefits of x-ray visibility for easy scaffold delivery and accurate implantation. This is an important advance for bioresorbable scaffolds, which have the potential to offer patients the benefits of a metallic stent without the complications of a life-long implant.”
“When physicians have first-hand experience with Fantom, they see the ease-of-use and clinical benefits of a thin-profile, x-ray visible, bioresorbable scaffold made with the Tyrocore polymer,” Reva CEO Reggie Groves added. “The first implant of Fantom in Italy with Dr. Cortese is an important step in preparing for commercialization in Italy.”
In a study published in last September’s issue of JACC: Cardiovascular Intervention, Reva’s Fantom product succeeded after six months.
The device was studied with 117 patients with single de novo native coronary artery lesions. The primary angiographic endpoint was mean late lumen loss at six months. The study’s primary clinical endpoint was major adverse cardiac events at six months, including cardiac death, myocardial infarction or clinically driven target lesion revascularization.
Short-term technical success, short-term procedural success and clinical procedural success was met in 96.6%, 99.1% and 99.1% of participants, the authors reported. The mean in-stent late lumen loss was 0.25 millimeters (+/- 0.40) after six months. The team reported observing binary restenosis in two patients.
Major adverse cardiac events happened in three patients within the six-month study period, including two myocardial infarctions and two target lesion revascularizations.
Scaffold thrombosis was seen in one patient, the team added.