MiCardia (Irvine, California), a company developing what it calls "smart" implants to treat heart valve disorders that use radio frequency (RF) energy to re-shape the device during or after the implant procedure, has received FDA 510(k) clearance for two of its products.
MiCardia said the FDA cleared its Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR. These are the first of the company's products under its Dynaplasty brand to receive U.S. market clearance.
MiCardia said the technology is designed for the percutaneous and non-invasive treatment of structural heart disease, including mitral valve regurgitation (MVR), tricuspid valve regurgitation and congestive heart failure (CHF).
According to the company, its technology provides devices that can be implanted into the heart and then "dynamically" adjusted, with a less-invasive method, either during or after a procedure for the proper shape and size to produce the best clinical outcome both at the time of the procedure or at subsequent post-operative intervals.
It says that the necessary modifications to shape and size can be viewed by ultrasound and then "activated" in real time without requiring additional invasive surgery. According to the company's website, the activation method involves accessing the implanted ring via a percutaneous femoral vein introduction and applying energy to the ring.
Paul Molloy, CEO of MiCardia, said in a statement, "This is a key regulatory milestone for MiCardia which involved extensive technical validation of the company's first generation annuloplasty system. It prepares the way for the progression of this highly unique and innovative Dynaplasty Technology and pairs with the commencement of the company's DYANA Phase I human study in Europe."
He added: "To our knowledge, MiCardia is the only company developing intra-operative, percutaneous and completely non-invasive, dynamically adjustable, implantable devices for the $15 billion annual CHF market."
Percutaneous valve repair and replacement devices represent a significant market opportunity worldwide, according to data from the Millennium Research Group (Toronto), presented last year at EuroPCR.
At that time, the total worldwide heart valve market was projected to be more than $720 million by 2010, with growth accelerating beginning this year, Medical Device Daily's sister publication, Cardiovascular Devices & Drugs, reported (CD&D, July 1, 2008).
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, clinically referred to as MVR. 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.
Among the currently emerging technologies for achieving minimally invasive mitral valve repair, MiCardia says Dynaplasty is the "only technology able to optimize mitral valve repair clinical outcomes intra-operatively, immediately post-operatively, and at later intervals as the disease condition continues to recur."
Such long term mitral valve competency management is performed today through re-intervention, rendering the aged and advanced stage patient at high risk of complications and death associated with repeat surgery, the company noted.
Ultimately, MiCardia says its technology will provide a reduced-risk alternative for MVR patients via intra-operative percutaneous or completely non-invasive mitral valve optimization.
While MiCardia touts the uniqueness of its mitral valve repair technology, several other companies also have offerings in this space, or are preparing such offerings.
Medtronic (Minneapolis), for example, launched a solution earlier this year that it says will significantly reduce the difficulty of valve repair and lead to more repair procedures in the future. That device – the Profile 3-D Annuloplasty Ring, used to repair failing mitral valves – received FDA approval in March.
Medtronic's device is "saddle-shaped," a company spokesman told MDD in May, and is designed to restore the valve to its natural shape (MDD, May 22, 2008).
Another company, Cardiac Dimensions (Kirkland, Washington), has a Carillon mitral contour system under investigation in Europe, South America, and Australia, which is designed for the percutaneous treatment of functional mitral regurgitation. The Carillon system combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors.
The device is delivered percutaneously via jugular access under fluoroscopic guidance. It is designed to be positioned, adjusted and anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral valve regurgitation (MDD, May 30, 2008).