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Press Release

HeartStitch® Presents Initial Clinical Results Of New Tricuspid Valve Repair At CSI Frankfurt Clinical Congresses

HeartStitch
Posted on: 25 Jul 18

FRANKFURT, Germany, July 24, 2018 /PRNewswire/ -- HeartStitch® has presented initial clinical data of its revolutionary tricuspid valve repair technique using only surgical sutures and pledgets to repair and promote remodeling of the tricuspid valve in 30 patients suffering from tricuspid regurgitation (TR).

Prof. Anthony Nobles, Chairman, CEO and Chief Clinical Officer of HeartStitch®, Inc. presented the data during the tricuspid valve forum which surprised many of the attendees by showing the only tricuspid procedure that did not leave an implant behind or did not distort the anatomy by changing the tricuspid valve into a bicuspid valve. The HeartStitch® technique called "HeartRose™" provides a surgical annulplasty to repair the tricuspid valve by remodeling the annulus back to its original size while maintaining the normal triple leaflet configuration of the native valve.

Thirty successful cases of tricuspid plication annulplasty using the HeartStitch® technique were performed by Dr. Yuri Pya, CEO and Chief of Surgery of the National Research Center for Cardiac Surgery (NRCCS) in Astana Kazakhstan at the National Cardiac Center, Astana, Kazakhstan. The initial cases were performed both with echo imaging and an open surgical setting to verify placement. Positioning was evaluated through a trans-jugular approach accessing the valve from the superior vena cava. This percutaneous approach provided a more direct route to the tricuspid valve.

After performing more than thirty successful cases Dr. Pya commented, "This is a revolutionary technique, the ability to suture the annulus from above by placing sutures through the annulus and placing the pledgets in the ventricular side giving the required strength to plicate the annulus and reduce down the diameter of the distended annulus without a prosthesis leaving only sutures and pledgets. I believe that this procedure can be reliably performed percutaneously using the Heart-Rose™ suture-based repair catheter through the jugular vein and using a combination of echo and fluoroscopy guidance. The primary benefit over the other percutaneous devices is that there is no implant left behind, the native valve leaflets are not damaged by attaching a clip and the normal anatomy is not distorted by turning the valve into a bicuspid valve. This is a pure surgical procedure that can now be introduced percutaneously, without surgery."

Prof. Dr. Achille Gaspardone, Director of Cardiology at Hospital of Sant'Eugenio (Rome, Italy), who has performed over 200 of the NobleStitch™ EL suture based procedures for PFO and ASD closure commented, "I have been a very strong supporter of the stitch as an alternative to implants for structural heart repair. During the last 2 years I have worked with HeartStitch™ to bring the technology to the tricuspid repair. The tricuspid has been the "forgotten valve" for many years and until the HeartRose™ there has not been an effective technique demonstrated for tricuspid repair of TR. Like the NobleStitch™ has done for PFO closure, I believe this will be the next big evolution in tricuspid valve repair."

Prof. Anthony Nobles, "This is the next step in the evolution of our suture-based platform technology. We have had tremendous acceptance of our technology for PFO closure with more than 1,200 cases performed and with the recent publication of our data for the PFO application showing an equivalent efficacy and superior safety profile over the implantable devices, this success has now been translated into several new indications including trans-apical access and closure, mitral valve repair and now tricuspid repair. We received extremely positive feedback at CSI for our HeartRose™ system which was shown for the first time to the attendees whose feedback included, this is the only plausible technique for tricuspid repair!"

About HeartStitch®

HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace.  HeartStitch® is focused on innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures.

The HeartStitch® products, NovaStitch™ and HeartRose™ are FDA cleared for vascular suturing and cardiovascular suturing in the United States.  HeartStitch® manufactures and markets the NobleStitch™ EL under exclusive license from Nobles Medical Technologies II, Inc.  NobleStitch™ EL is FDA cleared for vascular suturing and cardiovascular suturing in the United States and CE Marked for vascular and cardio-vascular suturing and PFO closure in the European Union and the Republic of Kazakhstan, respectively.

HeartStitch® is a registered trademark of HeartStitch, Inc.

NovaStitch™ for cardiac suturing and transapical access and closure

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8348962, 8469975, 8496676, and 8709020.

HeartRose™ for suturing an anatomical valve

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8348962, 8469975, 8496676, 8709020, and 8771296.

NobleStitch™ EL for PFO closure

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.

For more on HeartStitch® visit http://www.heartstitch.com

For more information, please contact shareholder representatives:

USA

Dru Dobbs

P. +1 714 427 6348

F. +1 714 427 6343

ddobbs@HeartStitch.com

In Kazakhstan

Kazbek Aubakirov

P. +7 777 5009005

kaubakirov@HeartStitch.com

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 25/07/2018

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