Structural heart focused HeartStitch and Nobles Medical today touted separate procedures utilizing cardiac sutures with the company’s Hearstitch ST and Noblestitch EL devices.
Nobles Medical Tech said that the NobleStitch EL device was used in the 1st percutaneous ASD closure and ASA repair and remodeling without the use of an implantable device.
The NobleStitch EL device closes the hole through a minimally invasive cardiovascular suturing procedure, the company said, with a routine cardiac catheterization procedure to secure the closure.
“This was the 1st time we used the NobleStitch cardiovascular suturing device in this way. We suspected that the patient, apart from the PFO, also had a small ASD, which was verified during intervention. We started by attempting to cross the PFO, but the ASA made accessing the PFO impossible. Instead we crossed the ASD located in the ASA. Prof. Nobles was consulting during the case to determine the viability to use the NobleStitch in these circumstances, and we elected to suture the ASD and collect enough of the septal tissue to remodel the ASA back to its almost normal structure. After this we were able to access the PFO and close it with a second NobleStitch EL. The NobleStitch allowed us to address these three structural heart abnormalities successfully without implantation of an umbrella, and without the inherent risks of having such a device (arrhythmia, embolization, late erosion),” performing surgeon Dr. Niels Nielson of Linkoping, Sweden’s Linkoping University Hospital said in a press release.
Nielson also sucessfully closed a patent foramen ovale in a 38-year-old patient, which the company says is the 1st patient to receive treatment for all 3 heart defects using the NobleStitch EL sutures.
“The NobleStitch EL was designed for cases like this. PFO closure is one of the many cardiovascular structure the NobleStitch EL can be used to suture. I was very pleased to see the NobleStitch EL provide this patient a safe alternative to open heart surgery or implanting a very large metal implant. Any 1st-In-Man is significant for a product and for the future of structural heart interventions. We look forward to expanding the number of cardiovascular suture repairs performed using the NobleStitch El,” HeartStitch CEO Anthony Nobles said in a prepared statement.
HeartStitch also touted the 1st 6 in vivo tests of its HeartStitch TA, used to remotely place sutures into the apex of the heart to facilitate large bore access to the left ventricle for treating structural heart defects.
“We have been working on this device for some time and today we wanted to test the device performance under extreme and challenging conditions to assure its safety. Dr. Pya brought the perspective of the cardiac surgeon to procedure which proved to be critical in the technique we have been using. This technology, which is based on the same successful suture technology we use in PFO closure, shows tremendous promise in allowing access and secure closure of the apex of the heart using only suture, the same technique currently used by surgeons in open heart procedures,” Dr. Michael Mullen of London’s St. Bartholomews Hospital said in prepared remarks.
The procedure took appoximately 4 hours to complete, HeartStitch said, and led to refinements in the HeartStitch TA procedure and design that the company said will be implemented later this month.
“I was very pleased with the procedures and impressed with the HeartStitch TA device. As surgeons, I am familiar with the benefits and outcomes of using suture rather than a bulky metal implant. These procedures today confirmed the potential for safe and effective access and closure of the apex using the HeartStitch device. I am very excited about the potential clinical benefit it will bring to my patients, allowing the less invasive approach to performing life saving structural heart procedures,” Dr. Yuriy Pya of Astana, Kazakhstan’s National Research Center for Cardiac Surgery said in a press release.
HeartStitch said it expects to perform further in vivo and ex vivo tests in April that will incorporate the input from these tests before the 1st-in-man clinical use of the system.
“The HeartStitch TA performed incredibly well. More importantly the input from our clinical investigators gave us essential feedback to prepare for the clinical use of the HeartStitch TA. We have implemented their feedback in the procedural technique and in the device design. After completing the required testing, we will look forward to testing the final design and technique in the upcoming tests and the subsequent clinical cases in Astana, Frankfurt and in the UK,” HeartStitch CEO Nobles said in a prepared statement.