Suture-Based Solution Corrects Structural Heart Defects

The system is composed of three devices for the release and attachment of non-absorbable polypropylene 4-0 sutures in three different steps:

The NobleStitch EL ‘S’ device allows the surgeon to place the first suture through the septum secundum;
The NobleStitch EL ‘P’ device allows the surgeon to place the second suture through the septum primum;
The “KwiKnot” device allows the surgeon to close the PFO by places a proprietary radiopaque polypropylene knot over the suture, eliminating the need to hand tie a knot.

Advantages of the system for treating PFO include no need for an implanted device, thus eliminating the subsequent risk of implant migration, dislocation, nickel allergy, late onset perforation, and erosion; no risk of thrombosis, and therefore no need for antiplatelet therapy or other medical treatment; and no interference with future transseptal procedures.

“Physicians continuously expressed to me their desire to have suture-based solutions rather than large metal implants left in the heart. Most physicians that have used the NobleStitch EL found it safe, easy to use, and have requested the same suture technologies to replace other implantable clips and devices,” said Professor Anthony Nobles, MD, inventor of the NobleStitch EL and Chairman, CEO and Chief Clinical Officer of HeartStitch. “With every new physician we proctor the response is universally one of 'I intend to use this in my patients as the first choice for closure. Eliminating the need for an anesthesiologist, we can perform the procedure safely under local anesthesia.”

“It is quite efficacious, and is possible to carry out in the majority of patients,” said Achille Gaspardone, MD, of San Eugenio Hospital (Rome, Italy), who presented data from several centers in Italy utilizing the NobleStitch EL system for PFO closure. “Most importantly, the system is safe because there is no metal device left behind, particularly on the left side of the heart.”

When the chambers of a human heart begin to develop, a tunnel is formed between the right and left atria of the heart in order to allow blood to flow directly from the venous to the arterial circulation, circumventing the non-functioning fetal lungs. Following birth, a pressure differential between the right and left atria forms to allow blood flow to the fully functioning lungs, and the tunnel eventually closes completely. When this does not occur, a PFO is formed, allowing blood clots and deoxygenated blood to o cross over to the arterial side. The presence of a PFO has been linked to a number of clinical issues, mainly strokes, migraines and chronic fatigue.

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