MiCardia (Irvine, California) reported the completion of the first U.S. implant of its Dynaplasty mitral valve repair technology. The surgery was performed last week at Beaumont Hospital (Royal Oak, Michigan) and was part of the company's European Dynamic Annuloplasty Activation (DYANA) study.
"The MiCardia device implanted easily and conformed well to the patient's mitral annulus," said Francis Shannon, MD, who is director of cardiovascular surgical research and quality outcomes at Beaumont. "The complete D-shaped ring was used to reinforce a complex repair of a flail leaflet segment using minimally invasive techniques. We are excited to be participating in the DYANA study and believe Dynaplasty technology will address a major weakness of current devices, namely their inability to deal with changes in valve shape and function after the initial repair procedure."
MiCardia said it is developing Dynaplasty technology for the treatment of structural heart disease, focusing initially on mitral and tricuspid valve disorders and as a method of interrupting a major element in the onset and progression of heart failure. According to the company, more than 15 million people in Europe and the U.S. have heart failure, of which more than 7 million suffer from mitral regurgitation.
"This is a major milestone for MiCardia and we are grateful for Dr. Shannon's expertise in helping develop this technology," said CEO Paul Molloy. "The Dynamic Annuloplasty Activation study involves patients from Europe who receive a device capable of activation post-implant and patients from the U.S. who receive a shape memory device that is not capable of activation."
Heart valve annuloplasty bands are used for the process of remodeling the fibrous tissue at the base of the valve, the annulus, thereby returning the valve to a state of leaflet coaptation and competency, MiCardia said.
Ischemic or degenerative conditions lead to the enlargement of the heart ventricle, causing the mitral valve annulus to distort and enlarge, which in turn renders the valve incompetent, allowing blood to reverse and leak back through the valve. In order to repair the incompetent valve, annuloplasty rings are commonly used in mitral valve repair operations.
The rings are implanted around the base of the valve to help maintain the natural shape, motion and flexibility of the annulus. Incomplete or inaccurate repair, or change in the anatomical conditions of the annulus, may result in post-operative residual or recurrent regurgitation, requiring high-risk repeat surgical intervention and often valve replacement with significant morbidity and mortality.
Molloy told Medical Device Daily that the problem with current technology to treat mitral regurgitation (valve leakage) is that in patients with ischemic valve disease the ventricle continues to change shape and in a short time the valve is going to leak again.
"It's like painting over the rust in some ways," he said.
In fact, Molloy said that an estimated 25% of all ischemic valve repairs will need to be adjusted within six months of the initial surgery. "For these patients there is no good alternative," Molloy said.
He added that the patient in this situation has three options: another open surgery to repair the valve again, which he said is not a good option because of the risks associated with having a second surgery in such a short period of time; the valve can be replaced, but he said this is not a good option either because repairing the valve is superior to replacing it in terms of survival and morbidities; third, do nothing other than take medicine, and "for those patients they are really on death row."
With MiCardia's Dynaplasty mitral valve repair technology, however, when the initial repair begins to fade the cardiologist has a chance to go in and adjust the valve without doing another open-heart surgery. he called the technology "smart, guided, and steerable" and said "nobody else can do this right now, it's a completely novel approach."
"We think both surgeons and cardiologists, if given a choice between a car with an airbag and one without would choose the car with an airbag," Molloy said. Likewise, he said, if they are given a choice between a valve repair device that can be readjusted in the future without another invasive surgery and one that can't, the company believes surgeons and cardiologists would chose the technology that is adjustable.
Molloy noted that a surgeon implants the device, but the adjustment can be done by an interventional cardiologist in an outpatient setting via a needle stick into the connector.
Earlier this year MiCardia reported what it said was the world's first "dynamic adjustment" of the mitral valve annular geometry on a beating heart (Medical Device Daily, Feb. 19, 2009). The procedure, performed by Professor Hans-Joachim Schafers, director of thoracic and cardiovascular surgery at Saarland University Hospital (Homberg, Germany) in February, marked the first dynamic adjustment of MiCardia's new Dynaplasty mitral valve repair technology in the company's DYANA study, designed to provide data for CE-mark approval of the company's Dynaplasty technology.
MiCardia received 510(k) clearance on the static version of its Dynaplasty system in the U.S. last year (MDD, Sept. 11, 2008). The company said it plans to submit U.S. implant data as part of its European CE-mark submission and in turn capture critical clinical data from its European study to support regulatory submissions and commercialization of its systems in the U.S. subsequently.
Molloy said the DYANA study is a non-inferiority study and its main purpose is regulatory. He said the company intends to embark on a more ambitious randomized study after receiving regulatory clearance because "ultimately we want to be able to say that an adjustable device can reduce severity of [mitral regurgitation]." But MiCardia needs to prove that before it can make that claim and before it does a study like that, Molloy said, the company wanted to be able to at least provide the device on a FDA 510(k) level.
MiCardia says it expects to complete enrollment and submit six month follow up data from the DYANA study in the fourth quarter as a prelude to European commercialization of "the world's first minimally invasive, beating heart valve repair system."