Structural heart focused medtech company HeartStitch said today that its HeartStitch Remo Pro suture technique was used in a world first procedure to repair the tricuspid valve of two patients as part of a feasibility trial of the technique and the supporting technology.
The procedures were performed by Dr. Yuri Pya at Astana, Kazakhstan’s National Research Cardiac Surgery Center, the company said. Both patients in the trial required tricuspid heart valve repair to remodel the annulus of their tricuspid valve to treat tricuspid regurgitation.
Patients in the feasibility test tolerated the procedure and have been discharged without complications.
“Structural heart surgery around the world is developing toward less invasive medical care. In most cases these less invasive techniques are beneficial for the patient, however to take an open surgical procedure and make it as effective when using the percutaneous techniques is a significant challenge. What we were able to demonstrate with these first two procedures was a major step forward in achieving the goal of percutaneous “surgical suture” based tricuspid valve repair. Since the completion of these successful cases we have now performed more than 10 cases in the last couple months all successfully. We believe this technique is the first clinical step in proving the safety and efficacy of this novel technique. I am very happy with this success and I thank Prof. Nobles, Dr. Lesbekov and my team, as well as those from the HeartStitch team, who participated in this clinical milestone,” Dr. Pya said in a prepared statement.
HeartStitch said that it is hopeful the procedure will eventually make it possible to perform critical heart procedures percutaneously through a small access from the jugular vein in lieu of open heart surgery.
“HeartStitch is the first of its kind medical device company in Kazakhstan and through its collaboration with Nazarbayev University and the National Cardiac Center of the innovation and clinical applications of these technologies has demonstrated that we are able to compete at the highest level in the world theater of medical device development and clinical implementation. This First in Man technique performed by Dr. Pya and his team will change the lives of two of my fellow Kazakh citizens, and will be the beginning of a treatment that will spread around the globe. I personally, am proud of what we have accomplished at EMS and Nazarbayev University to make this possible and I look forward to continuing to bring the HeartStitch Remo Pro to the world market,” HeartStitch subsidiary EMS director Kazbek Aubakirov said in a press release.
“This is our second new innovative first in man of a new procedural technique with Dr. Pya and is a historic day for all of us. This was the first step in the clinical development of our latest suture-based device the HeartStitch Remo Pro for treating mitral regurgitation. The success of these two cases has provided critical physician feedback to our design that will be implemented in our upcoming First in Man clinical testing of the new HeartStitch Remo Pro dual needle system which is planned in the next 90 days. We believe this will change the face of structural heart surgery, adding another treatment to our line of suture based structural repair devices which already include the HeartStitch Access Pro for trans-apical access and closure, the HeartStitchCoap Pro for mitral valve repair and the NobleStitch EL for PFO and ASD closure, which recently published its data demonstrating superior safety in percutaneous suture based closure,” HeartStitch chair & CEO Anthony Nobles said in a prepared release.
In June 2016, HeartStitch touted the 1st-in-man use of the company’s HeartStitch technology in a transapical access and closure procedure at the National Cardiac Research Center in Astana, Kazakhstan.