The one-year results from CeloNova Biosciences’s first-in-man trial for its Catania stent with Polyzene-F—which revealed an acute angiographic and procedural success rate of 100 percent—prompted CEO Thomas A. Gordy to tell Cardiovascular Business News that the company “is providing a simple solution to a complex problem.”
The Catania system has a 35- to 40-nanometer surface treatment of Polyzene-F, a synthesized, inorganic, biocompatible polymer that is anti-thrombotic, anti-inflammatory, bacterial-resistant and “cloaks the device’s presence from the body to promote healthy endothelial cell growth without stimulating platelet activation,” according to the Newnan, Ga.-based CeloNova.
The researchers presented the 12-month results of its ATLANTA trial [Assessment of The Latest Non-Thrombotic Angioplasty], a prospective, single-center, non-randomized, single-arm study, at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference. The study was led by by Corrado Tamburino, MD, PhD, director of cardiology at Ferrarotto Hospital, University of Catania, in Italy.
Of the 55 cases in ATLANTA, they included 41 were male patients with a mean age 58 years. Of those patients, 34 percent had diabetes, 60 percent had hypertension, 55 percent had hypercholesterolemia and 69 percent had a previous MI. Also, the researchers noted that 64 percent had vessels ? 2.75 mm. The target lesion revascularization at one year was 10.9 percent.
The investigators said that the results showed zero percent ARC stent thrombosis, death, MI, stroke or CABG. Target lesion revascularization was 10.9 percent with a binary restenosis rate of 6.8 percent (five of the 74 lesions analyzed at 12 months). They also noted that all patients stopped dual-anti-platelet therapy after 30 days, but continued taking aspirin throughout the 12-month period.
According to Gordy, the results suggest that the stent could prove particularly useful for patients who are at risk for bleeding and cannot comply with the dual-anti-platelet therapy.
While he is encouraged by the technology’s one-year results, he said that the company is looking to the future with a different ideological approach.
“The medical industry has lost its way. Too much time is spent on trying to demonstrate marginal differences between products. Competitors block each other from the product, even if the opposition’s product has clinical value. We play crazy commercial games,” Gordy said.
He added that “the stent industry is a prime example. Billions of dollars are spent to prove whether one stent has a marginal difference in binary restenosis or late loss, instead of spending that money on real long-term problems that need to be corrected. Decisions in medicine are currently not medically-based—they are too commercially driven.”
“We need to drive our business based on good medical judgment for patients on the gurney or the operating room table,” he concluded.