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Apica Cardiovascular Release: First Live Case With Innovative Transapical Access Technology At EACTS



11/11/2013 10:16:45 AM

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11 November 2013 – The use of Apica’s innovative transapical access technology was successfully demonstrated for the first time at the 27th European Association for Cardio-Thoracic Surgery (EACTS) congress in Vienna. EACTS is one of the largest cardiac congress in the world, with around 6,500 participants.

A transapical aortic valve replacement procedure using the Apica access, stabilisation, and closure (ASC) system, conducted by Dr. Joerg Kempfert and Dr. David Holzhey live from the Hertzzentrum in Leipzig, Germany, received a very positive response.

“The Apica ASC system is an easy-to-use method for achieving aortic valve replacement transapically, standardizing apical access and closure”, commented Dr. Kempfert. “My experience with this device in our clinic to date has shown reliable, rapid, and completely dry apical closure, leading to a shortened procedure time, minimal blood loss and reduced apical access site complications”.

Apica’s ASC system facilitated a truly minimally invasive approach in a complex case. The patient presented with a very severe aortic stenosis.

During the procedure, the ASC system simplified apical access and closure despite a challenging anatomy with significant fatty tissue. With the support of the ASC system, the procedure could even be performed with a "non-rib spreading" technique using a soft-tissue retractor. At the end of the procedure, the apical access was securely closed without a single suture.

“We have been tremendously encouraged by this first successful public demonstration of our innovative transapical access technology”, added James L. Greene, CEO of Apica Cardiovascular. “This reinforces our confidence that our ASC system will soon be routinely accepted as a new standard of care for transapical aortic valve replacement procedures".

The ASC system is a breakthrough enabling platform technology that facilitates the delivery of replacement aortic and mitral valves through the chest wall and apex of the beating heart. The ASC system both seals and stabilises the tissue of the access site during therapeutic device delivery, minimizing loss of blood from or induction of air into the beating heart. On completion of the therapeutic treatment, it standardises apical access and closure, leading to safer heart operations, decreased procedure time and reduced procedural challenges associated with transapical access and closure.

The Apica ASC system received CE Mark approval in August 2013, demonstrating an excellent safety profile with 100% technical success, superior ease-of-use and reductions in both blood loss and operative time. Follow-up assessments of patients showed that the system provided robust closure, with no post-operative apical bleeding complications and no degradation of left ventricular function.

Following CE Mark approval of the Apica ASC system, the company is currently starting a post-market clinical follow-up registry in limited centers in Germany.

About Apica Cardiovascular.

Apica Cardiovascular Limited is an Ireland-based medical device company committed to developing technology enabling the delivery of transcatheter valve therapy for aortic valve and mitral valve replacement and LVAD implantation without the need for cardiopulmonary bypass.

The company’s lead device is its access, stabilization, and closure (ASC) system, which enables and standardizes the delivery of aortic and mitral valves through the chest wall and apex of the beating heart with minimal blood loss, reduced complications and a shortened procedure time.

For further information, please contact:

Richard Kenyon

richard@rkpr.co.uk

+44 7831 569940

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