Advanced Personalized Treatment for Tricuspid/Mitral Regurgitation

• Category: Medical Devices
• Investment Status: Pre-Seed
• Medical Field: Cardio-Vascular
• Patent Status: PCT
• Medical Center: Ha'Emek medical center

• Inventors: Dr. Yoav Turgeman
  Eran Hirshowiz
  

Tricuspid regurgitation (TR), or tricuspid insufficiency, is a disorder caused by failure of the tricuspid valve to close properly during systole. This results in some blood flowing backwards (the opposite of the normal direction) into the right atrium each time the right ventricle contracts.

Moderate to severe tricuspid regurgitation affects about 1.6 million patients in the United States, but only about 8,000 undergo surgery annually which means that there are a very large number of patients with significant TR that remains untreated.

Tricuspid regurgitation (of various degrees) may be detected in 80-90% of patients referred for routine echocardiography. The average prevalence of significant TR (> grade 2\4) may reach 10.2% of the total population with echocardiography studies. Significant TR (moderate or more) is associated with increased risk of heart failure and decreased survival.
Surgical valve repair or replacement would usually provide a cure, but are regarded as high risk procedures due to patients’ unique risk profile (e.g. advanced age at the time of diagnosis, co-morbidities and history of previous cardiac surgeries). The surgical option to repair severe TR (as a single indication for operation) is therefore often abandoned. Currently there are no solutions available on the market for minimally invasive treatment.

The solution – a plug device 

Device composed of:

1. Anchoring net element – shaped such that it may be implanted superiorly to A-V valve, The net is perforated by a series of apertures. One or 2 apertures should be occluded by dedicated plug, in front of the regurgitant hole, mimicking FHD concept
2. Occluding plug – shaped such that it may be inserted into one of the apertures net element confronting the regurgitant hole.
3. Delivery system -into which the other two components are delivered to the cardiac valve, placed or retrieve

Advantages
1.Simple / Easy be handle and practice
2. Can be temporary & removable
3.Personaly adjustable by pre procedure 3DE
4.Suitable for both Functional & Organic (Rh, post MVR, Carcinoid, IE)
5.Can be used for both TR & MR (via Trans. approach)
6. Can be implanted in the presence of pacemaker leads
Device success :Reduction of 50-70% of regurgitant volume