Data on Reva's Fantom Bioresorbable Vascular Scaffold Presented at TCT
September 22, 2018—Reva Medical, Inc. announced that four key data sets evaluating the company’s Fantom bioresorbable scaffold (BRS) were presented at TCT 2018, the Transcatheter Cardiovascular Therapeutics conference held September 21–25 in San Diego, California.
The presentations at TCT included new procedural data from an indication-expansion study in patients experiencing ST-segment elevated myocardial infarction (STEMI), as well as positive clinical and imaging results of the Fantom BRS through 2 years.
New data from the FANTOM STEMI pilot study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in a series of nine patients with STEMI. Patients experiencing STEMI are a new patient population for Fantom. The company noted that although these patients have a higher risk of complications than stable patients, the characteristics of their arterial blockages are typically well suited to BRS treatment.
Lukasz Koltowski, MD, who is from the Medical University of Warsaw in Warsaw, Poland, presented the data at TCT. In the company's press release, Dr. Koltowski commented, “The first priority when treating heart attack patients is removing the arterial blockage to restore blood flow to the heart. The data presented today demonstrate that Fantom, which is x-ray visible and easy to use, works effectively during these emergency procedures. Many heart attack patients are young with single blockages in their arteries, and the Fantom bioresorbable scaffold creates an opportunity for recovery without the risk of a permanent metal drug-eluting stent.”
Clinical results from the FANTOM II study demonstrated the safety and efficacy of Fantom BRS at 2 years with a 5% rate of major adverse cardiac events and one very late scaffold thrombosis event for a rate of 0.4%. These data were presented by Yuichi Saito, MD, from Yale University School of Medicine in New Haven, Connecticut.
Additionally, optical coherence tomography imaging results from the FANTOM II study were presented by Neils Holm, MD, from the Aarhus University Hospital in Aarhus, Denmark. The 2-year data showed an excellent healing profile for Fantom with sustained vessel lumen patency and no evidence of chronic scaffold recoil through 2 years.
Finally, Ulf Landmesser, MD, Professor of Cardiology at Charité Universitätsmedizin Berlin in Berlin, Germany, delivered a comprehensive presentation of the Fantom BRS program at TCT. Prof. Landmesser reviewed available clinical data and provided an update on the Fantom postmarket trial, which is currently enrolling in Europe to evaluate the safety of Fantom in routine clinical practice.
Reva Medical's sirolimus-eluting Fantom and Fantom Encore BRS are designed for the treatment of coronary artery disease. Fantom is currently available in Germany, Switzerland, Austria, the Netherlands, Belgium, Luxembourg, Italy, and Turkey.