INNOVATIVE THERAPY
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The AccuCinch® Ventricular Restoration System
What is the AccuCinch System?
As the only completely transcatheter therapy to treat the enlarged left ventricle, the AccuCinch Ventricular Restoration System is a fundamentally different and innovative device-based therapy designed to improve the structure and function of the heart.
Where should it be used?
For HFrEF patients who remain symptomatic despite guideline-directed medical therapy, early clinical data suggests that the AccuCinch System may provide an effective treatment option by filling the gap between medication or cardiac resynchronization therapy, and left ventricular assist devices (LVADs) or a heart transplant.
What is the AccuCinch System intended to do?
- Reduce the size of the left ventricle and reduce ventricular wall stress
- Provide support and strength to the left ventricle
- Initiate reverse-remodeling to improve myocardial contractility and overall cardiac function
- Reduce symptoms
- Improve functional capacity
- Improve quality of life (QoL)
The Benefits of AccuCinch
AccuCinch is a fundamentally different therapy
Benefits of AccuCinch:
- Directly targets left ventricular (LV) dysfunction and dilation
- Percutaneous trans-femoral arterial-retrograde, not trans-septal or trans-apical
- Preserves the natural mitral structures
- Preserves all future treatment options
AccuCinch is the only system that:
- Reduces LV dimension
- Reduces LV volume
- Directly supports LV wall
- Releases mitral apparatus
- Reduces tenting
How It Works
AccuCinch
During the minimally invasive AccuCinch procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched.
- During the AccuCinch procedure, the left ventricle is accessed with a guide catheter through the aortic valve.
- A guide wire is navigated in the left ventricle behind the chordae against the LV wall to provide access for the TracCath.
- The TracCath provides a simple template for anchor placement.
- A series of anchors are placed into the LV wall below the mitral valve.
- A cinching cable connects the anchors and spacers and is cinched and locked in place.
- The cinch cable connects the anchors, separated by spacers to distribute a constant and predictable force across anchors.
- The cinch is secured with a nitinol lock to maintain the cinch.
LOOKING FORWARD
Promising findings to date
Early data has demonstrated that the AccuCinch System may enable improved functional capacity and quality of life for patients, and potentially enable reverse remodeling in patients with heart failure.
Leading heart centers in the United States and Europe are evaluating the benefits of the AccuCinch® Ventricular Restoration System in patients who have symptomatic heart failure with reduced ejection fraction.
Currently, patients are actively being enrolled in The CORCINCH-HF Study, a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation.
- The study is designed to enroll 400 patients at up to 80 centers worldwide.
- The study will ultimately follow patients through five years post treatment to track long-term results.
- The study has a unique design allowing initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached twelve months of follow-up. (ClinicalTrials.gov Identifier: NCT04331769 https://clinicaltrials.gov/ct2/show/NCT04331769?term=ancora+heart&cond=heart+failure&draw=2&rank=4)
Cardiologists are evaluating the ability of the AccuCinch System to reduce diastolic and systolic dimensions and improve LV function.
Limited LV wall motion prior to cinching
Improved LV wall motion following cinching*
*Initial results, at six month follow-up