Ventricular Repair Device for Heart Failure Patients, Cardiac Success Ltd

Left ventricular dysfunction often develops in patients with coronary artery disease, which leads to negative remodeling with increased LV chamber size. As ventricular dimensions increase, the mitral annulus dilates and papillary muscle displacement tethers leaflets, causing functional mitral regurgitation (FMR). Increasing LV dimensions and wall stress in combination with FMR increase the cardiac workload, which further degrades function with progression of LV remodeling.

The most common type of MV repair performed in FMR is an undersized ring annuloplasty (Ring). However, this technique has been associated with suboptimal outcomes, and a high incidence of MR recurrence at mid-term follow-up. To decrease the prevalence of recurrent MR and improve clinical outcomes, several adjunctive techniques have been proposed to concomitantly address the subvalvular apparatus when performing MV repair. One of these techniques involves papillary muscle approximation utilizing a papillary muscle sling. Small scale clinical studies have demonstrated that the Ring+Sling is a feasible and more effective alternative to a Ring repair for the surgical management of FMR.

Cardiac Success Ltd. Is developing an innovative papillary muscle sling implant and delivery system to be introduced via the transfemoral artery. This sling implant will have a long-term beneficial effect on LV remodeling and provide more effective restoration of the mitral valve. The sling implant aims to increase Ejection Fraction (EF), Reduce MR and improve Cardiac Output.

Company status:

Intellectual property- company has broad IP coverage addressing the method, implant design and delivery system design. 2 patents have already been granted in the US, and 2 more patents are officially allowed.
Experimental proof of concept- Chronic surgical implantation in sheep, full transfemoral procedures in porcine, Cadaver study in isolated hearts and transfemoral procedures in full torso cadavers.
Company is currently in the stage of freezing the design, V&V plan and preparing for FIM in 2021.