Annuloplasty Ring Cleared for U.S. Market
The European-based Sorin Group received marketing clearance from the Food and Drug Administration for the MEMO 3D Semirigid Annuloplasty Ring, details are included in a company press release. The product is used for the treatment of mitral valve defects.
The new annuloplasty ring is manufactured with a shape memory, superelastic alloy core. This design promotes maintenance of the device’s native shape and function. The ring is also coated with carbofilm, which is added to enhance the hemocompatibility of the device. Another key feature of the ring is progressive flexibility from the anterior to the posterior aspect of the device.
The design is founded on a cell-structure vision. This allows the device the opportunity to mimic the native mitral annulus’s physiologic three-dimensional motility. This design also accommodates the anatomic saddles shape of the annulus.
Features to support ease of placement include a white guide line that simplifies suturing the ring and a low profile holder with spacing guidelines. An oval cross section of the silicon sheath is also included.
The mitral valve’s role is to close fully and completely, preventing return of blood flow back into the atrium. This limits the full capacity of the ventricle to pump blood effectively. This condition is treated with either annuloplasty, with a device such as the MEMO 3D implanted, or valvuloplasty. Normal cardiac activities is supported by the MEMO 3D with optimized structural stress throughout the device which is maintained throughout the cardiac cycle.
The device is already being used in Europe. One clinician in Germany has placed over 140 of the implants.
September 28, 2007 Related topics: Product Approval & Certification, Cardiology