CE Mark For CoAp Pro Mitral Valve Repair Announced by HeartStitch

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April 19, 2018

The CoAp Pro expands HeartStitch’s product line of cardiovascular devices, increasing the ability to provide surgeons and interventional cardiologists with a toolbox of solutions for treatment. Today the company announced it has received the CE Mark in the European Union for treatment of mitral valve repair.

This approval will provide physicians the ability to remodel the leaflets of the mitral valve and reestablish proper coaptation.

Prof. Dr. Achille Gaspardone, Director of Cardiology, Department of Medicine, Ospedale, S. Eugenio – ASL RMC, Rome Italy commented, “I am especially pleased to see HeartStitch® receive this approval, because it provides the ability to use suture to remodel the mitral valves rather than the need to place a prosthetic device in the leaflets. In my opinion it is a significant advancement to the treatment of Mitral Regurgitation.   Personally, I have seen the development of this device from its inception and have participated in the clinical testing, and with my extensive experience with the use of the NobleStitch™ EL for PFO closure it was a natural evolution for me to use this technology.”

“I have been working with the NobleStitch™ and HeartStitch® technologies for more than eight years, and I have seen the development of these devices as they have gone from prototype, to clinical testing, and finally to daily clinical use,” comments Dr. Michael Mullen, Chief Medical Officer of HeartStitch®.  Dr. Mullen added, “The recent advances to perform this procedure through normal venous access were made following the work we did testing in a clinical model. The feasibility of suture-based Mitral edge-to-edge ‘Alfieri’ stitching is now a reality.”

Dru Dobbs, President of HeartStitch, Inc., stated, “With each new device we are continuing to grow HeartStitch to become the Global Leader in Cardiovascular solutions.  While the CoAp Pro has an advanced design, it still retains the intuitive nature and ease-of-use which is the cornerstone of our cardiovascular device line.   In creating new suture-based solutions to treat cardiac disease we continue to provide physicians products that become their first choice to deliver the best outcomes for their patients.”

Onn the CoAp Pro CE Mark, Prof. Anthony Nobles, stated, “This CE Mark again shows that we have the ability to continue to grow our technology platform for many indications. The NobleStitch™ EL has played a significant part in our Company’s ability to have physicians believe in percutaneous suture-based solutions for the treatment of structural heart disease. Doctors worldwide have been asking me for several years to use the NobleStitch™ EL for these indications.”

Dirk Segers, Vice President of Sales and Marketing for HeartStitch® added, “The CoAp Pro will allow physicians to repair the leaflets of the mitral valve in a less invasive percutaneous and suture-based procedure.  European physicians are leading the way in their willingness to embrace our suture-based technology.  I find as I speak to physicians and distributors throughout Europe that they are now asking us to provide them with information on what our next product will be; they are looking to anticipate how they can expand our offerings to patient care.  HeartStitch® continues to define the new approach to cardiac interventions.”



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