Reva Medical (ASX:RVA) has expanded its commercial operations into Switzerland, the company said today, with the first implant of its Fantom bioresorbable scaffold.
The scaffold is made from Reva’s tyrosine-derived, radiopaque polymer, rendering Fantom visible under fluoroscopy – a characteristic that is unique to Reva’s product.
Fantom also sports 125 micron struts, which have held up in clinical trials. Data from the Fantom II study showed that Reva’s product helped maintain vessel patency after six and nine months with 0% malapposition and 99% strut coverage.
“Following my experience with Fantom, I have been able to see first-hand how Fantom’s technology with the Tyrocore polymer offers simplified deliverability, single-step inflation for ease of use, and radiopacity for accurate scaffold placement,” Dr. Gregor Leibundgut, who implanted the device, said in prepared remarks.
“Bioresorbable scaffolds have the potential to offer comparable short-term treatment without the long-term complications of a permanent metallic stent. This is an important treatment option and we are happy to offer it to our patients.”
“Fantom, made with Reva’s novel polymer called Tyrocore, is an exciting advancement in bioresorbable scaffold technology that has the potential to positively impact clinical practice for physicians and patients,” CEO Reggie Groves added. “With the launch of Fantom in Switzerland, Reva continues to execute on our growth plan with direct selling efforts in the first phase of Fantom’s targeted launch.”
In a study published in the September issue of JACC: Cardiovascular Intervention, Reva’s Fantom product succeeded after six months.
The sirolimus-eluting 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.
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