Mitral regurgitation (MR) is the abnormal reverse flow of blood due to leakage through the mitral valve during each heartbeat. A common heart valve disease, MR affects about 5% of Western populations, and approximately 1% of patients will require medical treatment. MR can be caused by an abnormal mitral valve, called degenerative MR (DMR), or an abnormal ventricle, called functional MR (FMR). DMR is preferably treated with valve repair, while FMR often requires valve replacement.
Degenerative mitral regurgitation requires open heart surgery
Today, significant degenerative MR is usually treated with mitral valve repair or replacement, an open heart operation. While highly effective, there are risks associated with surgery and there is a period of necessary recovery. This means time away from work, and time away from normal activities and family. Unfortunately, some patients with other health problems may not even be candidates for surgery, due to prohibitive risk. There is an unmet clinical need.
Patients with degenerative MR need a safe and simple therapy.
Vesalius Cardiovascular is currently developing the Calla transfemoral mitral valve repair system, a biomedical device and delivery system that can be advanced percutaneously to the heart for the treatment of degenerative MR, the most common variety of MR.
For the Calla TMVr system, the principles of surgical mitral valve repair are utilized, but sternotomy, heart-lung bypass, and cardiac arrest - components of an open heart operation - are not required. Decades of surgical experience have proven the effectiveness and durability of our applied surgical principles. Today, Vesalius pushes forward to provide the benefit of surgery, but without the need for surgery.
Percutaneous procedures like TAVR for structural heart disease have shown us the immense potential of a percutaneous approach. The less invasive nature of percutaneous procedures means a shorter hospitalization, and an earlier return to work and normal activities, as early as 24 hours. For a busy and active patient, this is perhaps the greatest benefit, both economically and for family life. And for the healthcare system, shorter hospitalization means less cost.
There is also a group of patients with other illnesses who are not candidates for surgery, due to prohibitive risk. This is where the Calla TMVr system could fulfill an unmet need, by offering an effective treatment for patients who are too sick to undergo traditional surgical therapy.
Calla will be implanted by a skilled cardiovascular interventionalist with expert knowledge of mitral valve disease, and transcatheter structural heart techniques. Calla is able to address both simple and complex degenerative problems with the same simple approach. Whether there is a single leaflet prolapse, or a complex case with multiple segments of leaflet prolapse, the implantation and repair technique is the same. This effectiveness and adoptability benefit places Calla above our competitors.
Left ventricular outflow obstruction with TMVR is a universal risk
Transcatheter mitral valve replacement (TMVR), a non-invasive replacement of the mitral valve, is required for some patients with FMR. However, TMVR can cause a potentially fatal complication known as left ventricular outflow tract obstruction (LVOTO), and this complication is possible with all existing TMVR solutions. This means that many patients in need of TMVR are not candidates for treatment, because of the risk of LVOTO.
Existing TMVR devices need a solution for LVOTO.
In parallel to Calla, Vesalius is developing the Orion TMVR Platform, a revolutionary device and accessory to enable optimization of transcatheter mitral valve replacement, by eliminating a risk common to all existing strategies. Orion definitively prevents LVOTO when used with any suitable TMVR device, thus increasing the treatable population of patients in need of TMVR.
Vesalius Cardiovascular Inc., 2016