The HeartStitch TA™ is a suture-based device that allows for transapical access and closure of the heart during transapical procedures, and will be an essential device for successful percutaneous transapical structural heart procedures including trans-catheter aortic valve replacements (TAVR). The HeartStitch TA™ will enable a physician to place sutures through the myocardium and apply an automated knot component (KwiKnot®) to seal the apex.
When the HeartStitch TA™ is utilized, the physician first places a needle stick under fluoroscopic guidance through the 4-5th intercostal space (ICS) in the ribs. Next, a guide-wire is positioned through the needle to maintain access. The HeartStitch TA™ is then placed over the wire through the ICS and into the apex of the beating heart. A technique known as “pre-closure” is then undertaken, during which the HeartStitch TA™ device draws its needles from inside the ventricle to capture the sutures. The resultant suture strands are then placed out of the way during the procedure. The integrated sheath is then placed into the apex while maintaining hemostasis, providing access during the required structural heart procedure. When access to the heart is no longer required, the physician then utilizes the KwikKnot® and cinches the knot flush to the endocardial surface of the apex and trims the excess suture as a final step.
Features: Easy 3-step process to deploy; suture-based closure; secure closure of apex; KwiKnot (automatically ties knot and trims suture)
Benefits: Suture based closure is the gold standard and preferred method of surgical closure; no implantable left behind; provides surgical suture closure percutaneously; simplifies the process, significantly reducing procedure time; simple learning curve for physician
Animation demonstrating use of the HeartStitch TA™ with corresponding live training video.
The HeartStitch MR™ device is the first suture-based technology available that allows physicians to perform an edge-to-edge technique percutaneously. This technique, popularized by Dr. Alfieri, rose in prominence with the recently acquired E-Valve device (MitraClip® Abbott Vascular), which places a clip across the leaflets to achieve the “Alfieri effect” type result. The MitraClip® is a complicated device with a procedure time of 1-4 hours. It requires placement in the leg, navigation though the aortic arch and deployment transeptally. The HeartStitch MR™ is deployed transapically, providing a simple modality for the physician.
The HeartStitch MR™ solution provides a direct approach to the mitral valve, avoiding the arch, the septal puncture, and the complexities of long catheter manipulations. Quite simply, the HeartStitch MR™ is designed to provide fast and secure suture placement to the leaflets while the heart is beating.
When deployed, the HeartStitch MR™ brings the 2 leaflet edges together by placing sutures from one edge to another, pulling the valve back together and thus allowing the outer edges of the leaflets to function normally. The HeartStitch MR™ uniquely allows for the use of local anesthesia and its simple design will enable physicians to quickly and safely perform mitral repair procedures on patients with moderate-to-severe and severe (3+ and 4+) MR.
Features: Easy deployment; suture-based closure; secure edge-to-edge stitch; transapical deployment; provides treatment for inoperable patients
Benefits: Shallow learning curve for physician; suture based solution, the known and preferred method of the edge-to-edge technique; no implantable left behind; local anesthesia used, avoiding post-op, open surgery complications; economic benefits of reduced length of hospital stay, etc.
Animation demonstrating use of the HeartStitch MR™.
The HeartStitch AP™ is designed to facilitate percutaneous transapical mitral valve repair and remodeling. The HeartStitch AP™ is in development by the same team of design engineers and staff behind the HeartStitch TA™ and HeartStitch MR™ technologies, led by Prof. Nobles.
The HeartStitch AP™ annuloplasty device provides staged plication of the posterior annulus with selective tailoring of more severely distended annulus by placing the same sutures normally placed in a standard open, stopped-heart procedure. However, with the HeartStitch AP™, the procedure is performed transapically and on a beating heart. This allows verification of function during the placement of each suture. The Company believes that the HeartStitch AP™ will provide the much-needed alternative to open-heart, on-pump surgical repair or replacement. The HeartStitch AP™ shares many of the same features and benefits as the HeartStitch MR™, and may address a broader spectrum of patients who may be candidates for mitral valve replacement as well.
HeartStitch®’s current products include the HeartStitch TA™, HeartStitch MR™, and HeartStitch AP™. The HeartStitch TA™ and HeartStitch MR™ have received US FDA clearance for use in performing vascular stitching in general surgery, including endoscopic procedures. The HeartStitch MR™ and HeartStitch TA™ are not intended for blind vascular closure. The HeartStitch TA™ and HeartStitch MR™ are CE marked for cardiovascular suturing in the European Union. The HeartStitch AP™ is an investigational device and not for use in the United States or the European Union.