Currently, the gold standard treatment for severe degenerative MR is mitral valve repair or replacement, an open-heart operation. While effective, there are risks associated with surgery in addition to a long physical recovery period. This means time away from work, normal activities, and family. Furthermore, some patients with underlying health problems may not be eligible for surgery, due to prohibitive risk. There is a significant unmet need.
Patients with degenerative MR need a safe and simple therapy.
Vesalius Cardiovascular is developing a delivery system and implantable medical device that can be advanced non-invasively to the heart for the treatment of degenerative MR.
Both components of a traditional surgical repair, chordal replacement and annuloplasty, are provided for effectiveness and durability.
For the Vesalius 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 the percutaneous approach. The less invasive nature of percutaneous procedures means a shorter hospitalization period, and an earlier return to work and daily activities. For a busy and active patient, this is perhaps the greatest benefit, both functionally and economically. For healthcare systems and hospitals, a shorter hospitalization means lower cost.
Due to associated illness, some patients are not candidates for surgery, due to prohibitive risk. This is where a non-invasive solution can eliminate the unmet need by offering an effective treatment for patients who are too sick to undergo traditional surgical operations.
Vesalius TMVr will be implanted by a skilled cardiovascular interventionalist with expert knowledge of mitral valve disease and transcatheter structural heart techniques.
Due to its design features, the Vesalius TMVr device is able to address both simple and complex degenerative disease. Whether there is single leaflet prolapse, or a complex case affecting multiple leaflets, the procedure is standardized and identical.
The effectiveness of a made to measure valve repair + the ease-of-use of a standardized delivery, is the hallmark of the Vesalius system.