HeartStitch was founded at the end 0f 2009 by Anthony Nobles, a successful entrepreneur with an established track record of development, commercialization, and M&A transactions in the medical device field.
HeartStitch was created to bring its established femoral closure suture technology to the treatment of several structural heart applications:
- Trans-apical access and closure
Treating structural heart disease, specifically heart valve disease, is one of the largest markets in medicine today. Symptomatic “aortic” valve disease affects more than 2 million people each year worldwide.Current therapy for aortic valve replacement is primarily open surgery or the newer TAVI, or trans-catheter aortic valve implantation. The utilization of TAVI procedures is growing as a result of the need to treat many patients unable to undergo open “on pump” heart surgery. TAVI procedures however, are performed either trans-femoral (from the artery in the leg) or trans-apically (from through a small hole in between the ribs).The current trans-apical market still requires a limited thoracotomy, an incision in the chest wall followed by spreading the ribs to access the apex to apply the closing suture. This is the primary reason that trans-femoral is the preferred method for doctors, until HeartStitch.
HeartStitch’s technology will provide a percutaneous closure to the apex through a small puncture without the painful spreading of the ribs, allowing the procedure to be performed without a surgical incision. Trans-apical approaches are significantly easier to perform, take substantially less time, and can provide better outcomes. The HeartStitch TA™ is the first ever suture closure solution for trans-apical closure.
- Mitral valve remodeling and mitral valve annulplasty to correct mitral regurgitation
Mitral regurgitation (MR) is the most common form of heart valve regurgitation and often results in heart failure. MR occurs when the leaflets of the heart’s mitral valve do not close properly, causing blood to flow backwards (regurgitation) into the left atrium, thereby decreasing blood flow to the body. Blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate blood to the body. MR is measured clinically on a scale from grade 1+ (mild) to 4+ (severe). When MR is considered clinically significant, surgery is usually recommended for patients who can tolerate it.
HeartStitch is currently focused on the development and commercialization of three devices in the structural heart space.
With a long history in suture-based closure from its sister companies Nobles Medical Technologies and Nobles Medical Technologies II, HeartStitch has utilized and applied its suturing technology in innovative products and applications for transapical structural heart procedures. Headquartered in Fountain Valley, California, HeartStitch’s unique suturing technology allows physicians to suture cardiac structures without the need for open heart surgery.
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™ & 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.