Devices Cardiology Regulatory

 News Release - April 12, 2018

HeartStitch(R) Inc. has received CE Mark for Its Suture Based Trans-Apical Access and Closure

HeartStitch®, Inc. Announces CE Mark for its Minimally Invasive Trans-Apical Access and Closure Device

ZWICKAU, Germany, April 12, 2018 -- (Healthcare Sales & Marketing Network) -- HeartStitch® Trans-Apical Access and Closure device provides safe and effective percutaneous trans-apical access for structural heart procedures and reliable closure. The proven suture-based technique emulates surgical closure without the need for open heart surgery or limited thoracotomy access (open surgical access to the heart between the ribs) when repairing structural heart defects in the left heart.

The HeartStitch® technology for Trans-Apical Access and Closure has received significant attention from interventional cardiologists after the recent publication of the NobleStitch Italian clinical study publication in the peer reviewed EuroIntervention journal this month. The NobleStitch data demonstrated the safety and effectiveness of placing sutures percutaneously in the heart. This success in the PFO space has launched an increased interest in suture-based solutions that eliminate the need for open surgical procedures by giving physicians a tool that can allow access though a percutaneous puncture directly in to the heart without an incision and then use sutures to safely close the hole.

Prof. Anthony Nobles, Chairman, CEO and Chief Clinical Specialist of HeartStitch, Inc., stated, "The CE Mark approval is another major step in the continuing process of establishing HeartStitch® in the market as an innovator in the field of structural heart repair.
   We strive and will continue to deliver to physicians a line of suture-based closure, repair and remodeling devices which provide the quality they demand for their patients with the ease of use they have been seeking. The ability to access the left ventricle to treat structural heart defects without surgery is a major step forward for HeartStitch®. We expect to bring this product to market this fall in Europe and will follow with USA thereafter."

Dr. Yuri Pya of the National Cardiac Research Center, Astana, Kazakhstan who was the first in the world to perform this procedure using our suture-based solution stated, "I am very excited about this technology and see great potential for our minimally invasive structural heart procedures. The device is revolutionary, allowing interventional procedures to be performed safely and effectively."

Dru Dobbs, Vice President of Manufacturing and Operations stated," We have worked very hard to bring these ideas through the development stages. Our top engineers collaborating from our offices in Germany, Kazakhstan and the US were responsible for creating this historic device. We now look forward to increasing our world presence as a leader in suture based structural heart market."

Dirk Segers, Vice President of Sales and Marketing for HeartStitch® commented, "The CE Mark approval gives the European medical community the ability to treat patients suffering ventricular disease using standard suture application for closure but utilizing our technology to deliver apical access in the beating heart. The benefits of this application allowing a less invasive treatment of patients suffering from structural heart disease has raised the awareness of our suture-based solutions."

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 the innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures. HeartStitch® currently markets the NobleStitch™ EL under license the NobleStitch™ EL device for cardiovascular suturing and PFO closure. HeartStitch™ develops new structural heart technologies through its international innovation development teams in California, Kazakhstan and Germany.

HeartStitch® is a registered trademark of HeartStitch, Inc.

HeartStitch® Access Pro

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.

HeartStitch® Coap Pro

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

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 www.HeartStitch.com

Source: HeartStitch

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