The Problem

Mitral Regurgitation requires Heart Surgery

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. Today, significant 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 MR need a safe and simple therapy.

Our Solution

Vesalius Cardiovascular is currently developing the Calla-TC3 mitral valve repair system, a biomedical device and delivery system which can be advanced percutaneously to the heart, for the treatment of degenerative MR (due to mitral valve prolapse), the most common variety of MR.

Surgically Inspired

For the Calla-TC3 mitral valve repair 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 these applied surgical principles. Today, Vesalius pushes forward to provide the benefit of surgery, but without the need for surgery.   

What Benefit?

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-TC3 mitral repair system could fulfill an unmet need, by offering an effective treatment for patients who are too sick to undergo traditional surgical therapy. 

Calla-TC3 will be implanted by a skilled cardiovascular interventionalist with expert knowledge of mitral valve disease, and transcatheter structural heart techniques. Calla-TC3 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 benefit sets Calla-TC3 above our competitors.

In parallel to our central focus, Calla-TC3, Vesalius is developing a revolutionary device to enable optimization of existing treatment of patients with MR who require valve replacement rather than repair.

.

Vesalius Cardiovascular Inc., 2016