MiCardia Receives Patent for Adjustable Annuloplasty Ring

The U.S. Patent and Trademark Office has granted a patent to MiCardia Corporation for an adjustable annuloplasty ring with subcutaneous activation port.

The patent will allow for minimally invasive or percutaneous access to activate an implanted cardiovascular device, according to the company. MiCardia developed the vascular access delivery system to use with its enCor_SQ Mitral Valve Repair system. The access port also may be used with a number of other implantable cardiovascular devices.

MiCardia’s Dynaplasty technology is designed to optimize mitral valve repair during and after surgery. Managing mitral regurgitation remains a significant problem for people with mitral valve disease. Left untreated or under managed, it can lead to more significant problems, including heart failure and death.

Currently, mitral valve regurgitation (MVR) is repaired surgically with the implantation of annuloplasty rings. However, some patients have residual MVR post-surgery and for 15 percent to 20 percent of patients, MVR significantly returns (3+ to 4+) within six to 12 months.

MiCardia’s Dynaplasty technology is the basis for enCor_SQ, which can be adjusted under beating-heart conditions to reduce the shape of the valve annulus to improve coaptation of the leaflets and reduce or eliminate regurgitation.

The enCor_SQ has received CE Mark and the annuloplasty adjustment procedure also has received reimbursement in select European countries. Using the Dynaplasty technology, this device addresses recurrent mitral regurgitation, days, weeks, months or years after the surgical procedure. The enCor_SQ technology allows recurrent mitral regurgitation to be managed on an out-patient basis, without the risk and cost of another cardiac surgery, the company claims.

MiCardia is conducting a clinical registry study in a number of European hospital centers to prove the potential clinical value of the enCor_SQ. Currently, more than 140 patients have had the enCor_SQ implanted and a number of them have had minimally invasive adjustments following recurrent mitral regurgitation both immediately after implant and up to two years after implantation.

“The issuance of this patent enhances our intellectual property portfolio and further demonstrates MiCardia’s commitment to developing percutaneous solutions to resolve recurrent regurgitation in patients with mitral valve disease,” said Jeff DuMontelle, vice president and general manager at MiCardia.

Based in Irvine, Calif., MiCardia is a privately held company developing a treatment technology that will allow adjustment of cardiac anatomy both intra-operatively and post-operatively. The MiCardia enCor Mitral Valve Repair System and the enCor_SQ Mitral Valve Repair System are not currently available for sale in the United States.