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October 2011

SYMETIS

  • Largest 2nd generation TAVI system clinical experience
  • Mid-term FIM study results to be presented at EACTS 2011 

 

Lausanne, Switzerland, October 2, 2011 – Symetis SA, a private Swiss company

developing new transcatheter aortic valve implantation (TAVI) systems, announced during the

Techno-College at the EACTS (European Association for Cardio-Thoracic Surgery) meeting

in Lisbon that it received CE Mark approval for its ACURATE TA™ transapical TAVI system.

The approval of this 2nd generation TAVI device, used to treat elderly patients with severe

aortic stenosis (AS) for whom open surgical repair is considered to be high risk, opens the

company to a market estimated to exceed $2 billion by 2014.

CE Mark approval:

Symetis performed two clinical trials of the ACURATE TA™ in Germany: a FIM trial (n=40)

and a Pilot study (n=50). The CE Mark was granted by the National Standards Authority of

Ireland (NSAI, www.nsai.ie) using a composite of patients from both studies, including 65

patients followed at 30 days, 30 patients at 6 months and 10 patients at 1 year. The

completion of enrolment in both studies translates to Symetis ACURATE TA™ having the

largest clinical experience to date of any 2nd Generation TAVI device in clinical trials or

approved for market. In addition, this dataset establishes a new standard for the approval of

future 2nd generation TAVI systems.

Clinical experience:

Both studies were single-arm, prospective, multicenter trials that enrolled high-risk patients

with severe AS. The combined patient cohort consists of 90 patients enrolled at six

investigation centers in Germany between November 2009 and July 2011. The primary

endpoint of both studies is 30-day mortality. Primary endpoints included procedure success

(95%) and safety/performance data collected at 30 days, 6 months and 1 year. The

secondary endpoints are MACCE, as well as ECHO parameters evaluating performance of

the ACURATE TA™. Dr. Joerg Kempfert will present the midterm results of the FIM trial at

the 25th EACTS Annual Meeting on October 3, 2011 in Lisbon.

Commercial launch:

The commercial launch of the ACURATE TA™ is taking place during the EACTS meeting,

with an initial focus on Europe. In parallel, a 150-patient, 15-center Pivotal trial will be

conducted to support the company’s US strategy. Also, a post-market surveillance study,

SAVI (Symetis Aortic Valve Implantation Registry), will begin with implantation of commercial

products.

Prof. Thomas Walther, Study PI, commented: “The Symetis ACURATE TA™ and Delivery

System received CE Mark approval after proving safety, efficacy and ease of use in the FIM

and Pilot studies. Patients had good functional outcome with low level of paravalvular leak,

which may be a good prognostic factor for long-term favorable outcomes. The CE Mark is an

acknowledgment of the solid development work delivered by the company’s team of

engineers.”

Laura Brenton, VP Clinical / Regulatory Affairs, said: “Investigators using the ACURATE TA™

in both the FIM and Pilot studies acknowledged its ease of use. The device’s simple

positioning and 2-step deployment, accompanied by tactile feedback facilitating release in the

correct annular position, were considered by all physicians to be the easiest delivery of a

transcatheter valve to date. The system’s simplicity translates into a shorter learning curve

compared to other TAVI systems currently on the market or still in clinical trials. Furthermore,

the robust dataset of 90 implanted patients also allows for comparison of the ACURATE TA™

to published statistics from 1st generation TAVI devices, suggesting comparable or improved

initial outcomes.”

Jacques R. Essinger, CEO of Symetis, added: “This is a major milestone in the development

of our company. While we will now expand our clinical experience through commercialization

of our ACURATE TA™ maintaining the highest level of clinical result will drive our commercial

strategy. We are very appreciative of our outstanding physicians and their expertise which

supported the clinical development of the ACURATE TA™.”