A Medical Device Daily
The Sorin Group (Milan, Italy) reported the first patient enrollment in the e-OPTIMA registry, which is designed to assess the clinical performance of the Optima drug-eluting Carbostent in the treatment of "real-world" patients in routine clinical practice. The registry will involve 1,000 patients throughout the world (except in the U.S. and Japan).
The new-generation Optima DES features a delivery system that the company said "allows for optimal DES expansion at implant." Patients with multiple stenoses in multiple vessels will be allowed into the e-OPTIMA registry, making it a real-world registry.
Optima features a drug-release system with reservoirs on the stent's outer surface, which Sorin said ensures targeted release only toward the vessel wall. It said that no polymer is used to carry the drug (Tacrolimus, a cytostatic drug produced by Astellas), "eliminating the shortcomings often associated with polymers."
The primary endpoint of e-OPTIMA is the incidence of adjudicated composite rate of cardiac death, myocardial infarction and clinically-driven target lesion revascularization at six months (device-related endpoint). Other major secondary endpoints are duration of dual anti-platelet therapy and thrombosis rate up to two years, and measurement of late lumen loss at eight months (in a sub-group population).
"The e-OPTIMA registry will allow us to further confirm the ... safety profile provided by the Sorin Group DES technology with a reduced dual-antiplatelet therapy as well as assess the Optima DES long-term efficacy," said principal investigator J. Koolen, MD, of Catharina Hospital (Eindhoven, the Netherlands).
He added, "It has been demonstrated that when increased attention is paid in optimizing DES implantation, its clinical safety and efficacy are enhanced thanks to improved stent strut wall apposition. The Optima ... delivery system was specifically designed to address this need."
The Sorin Group said the Optima system offers "the unique combination of patented polymer-free drug reservoir and the proven anti-thrombotic and potentially pro-healing integral Carbofilm coating. The innovative delivery system has been designed to improve device deliverability and optimize DES expansion."
1st European procedures with MitraClip
Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, said that the first two patients have been treated with its MitraClip system in Hamburg, Germany. Percutaneous mitral repair with Evalve's MitraClip device is performed by physicians in the catheterization laboratory.
The MitraClip system is the first commercially available device that enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR), the second-most-common type of heart valve insufficiency in Europe and most common in the U.S., affecting millions of people worldwide.
In both Europe and the U.S., the vast majority of patients are untreated, which leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder and ultimately leading to heart failure.
The first European patients were treated by the team led by Drs. Olaf Franzen, Dietmar Koschyk, Hendrik Treede and Joachim Schofer at the University Heart Center in Hamburg.
"The immediate results after implanting the MitraClip device have surpassed our initial expectations," said Franzen, an interventionalist for adult structural and congenital heart disease at the center.
"The patients we treated last week have heart failure and were considered to be high-risk surgical patients," said Thomas Meinertz, MD, chairman at University Heart Center. "Now with the availability of the MitraClip system, we are able to treat these patients with a much less invasive percutaneous alternative for mitral repair."
"This new therapy may be an excellent alternative for this group of patients with heart failure," said Herrmann Reichenspurner, MD, head of cardiac surgery and medical director at the Hamburg center. "As a cardiac surgeon, there are times when operating on this type of patient is not feasible due to the high risk of mortality and post operative morbidity. Now there is another treatment option."
The MitraClip system is commercially available in Europe and Evalve has initiated training in support of the European launch. Five additional treatment centers are in the process of scheduling treatment of their first group of patients: Glenfield Hospital (Leicester, UK); Hospital San Rafaelle (Milan, Italy); Cardiovascular Center Frankfurt (Frankfurt, Germany); Ferratoto Hospital (Catania, Italy); and Academic Medical Center (Amsterdam, the Netherlands).
"These first procedures in Europe mark a significant milestone for people worldwide suffering from the serious effects of MR," said Ferolyn Powell, president/CEO of Evalve. "The MitraClip system offers a new alternative to surgery for mitral valve repair which up until now was the only option to intervene."