The 251-patient study looked at individuals in North America with aortic valve disease who are implanted with the device, the Milan, Italy-based company said.
Results showed a mean reduction in gradient valve sizes, with 96% of patients in the New York Heart Association class I or II, improved from 54% at NYHA class III or IV before the implantation, Sorin said. The rate of freedom from structural valve deterioration was 99.5%, the company said.
“Aortic valve stenosis is the 3rd most frequent heart disease and leads to approximately 100,000 aortic valve replacements and 15,000 deaths each year in North America. We welcome new technologies that can help us improve patient survival and quality of life. To this end, we were pleased to see these data reinforce the excellent safety profile and hemodynamic benefit observed in previous trials of the Solo valve. Despite the older age, comorbidities and overall risk profile associated with this population, these patients experienced excellent recoveries after one year. The Solo Smart valve keeps the native aortic and annular functional capacity intact, unlike a stented valve. There is no other valve like it available today,” lead author Dr. David Heimansohn of Indianapolis, Ind.’s St. Vincent’s Heart Hospital said in a press release.
The results were consistent with an earlier 3-year 804-patient trial that showed beneficial survival, morbidity and functional status outcomes, the company said.
“Sorin is committed to developing groundbreaking cardiovascular devices that help cardiac surgeons deliver a precise, tailored solution for each patient. In addition to providing clinical benefit and improved convenience for the patient and surgeon, a stentless procedure that takes less time to perform is more cost-effective for the hospital and the healthcare system overall,” cardiac surgery business unit president Michel Darnaud said in a prepared statement.
The merger won approval from U.S. anti-trust regulators in April. Sorin’s sales account for more than 60% of the combined entity’s total sales. Cyberonics had around $290 million in 2014 revenues, 1 production facilities and 650 employees, compared to Sorin’s sales of nearly $1 billion, 10 manufacturing sites and 3,900 workers.