SORIN GROUP INVESTS IN ENOPACE BIOMEDICAL

October 17, 2011 - SORIN GROUP INVESTS IN ENOPACE BIOMEDICAL, EARLY STAGE COMPANY FOCUSED ON INNOVATIVE SOLUTION FOR HEART FAILURE PATIENTS -


Investment will drive development of a unique interventional technology for the largest unmet clinical need in the cardiovascular field –

Sorin Group (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced a minority investment in Enopace Biomedical, an early-stage company focused on the development of a neuromodulation system to treat patients with congestive heart failure.

Enopace’s technology consists of a minimally invasive, implantable neurostimulator for heart failure patients that increases cardiac efficiency by reducing left ventricular workload. Sorin’s $7 million investment will finance the initial clinical studies of this technology as well as ongoing product development. Sorin Group joins Rainbow Medical as an investor in Enopace.

Heart failure is the largest unmet clinical need, with the highest associated healthcare costs, in the cardiovascular world today. In Europe and in the United States around 15 million patients suffer from chronic heart failure. The United States healthcare system spends over $40 billion to treat these patients. CRT (cardiac resynchronization therapy) devices currently address part of the systolic heart failure population, but no approved therapies exist for diastolic patients. Neuromodulation systems represent a significant opportunity to expand the clinical indications for device-based heart failure therapy and, moreover, enhance the treatment for congestive heart failure patients... Sorin's Press Release -

Symetis : ACURATE TA(TM) Aortic Bioprosthesis Receives CE Mark Certification on Sept. 30th 2011

10/03/11 - 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™... [PDF] Symetis' Press Release -

Alere : HABIT Study Shows That Home BNP Testing May Allow for Earlier Interventions & Facilitate Better Management of Heart Failure Patients

Oct. 4, 2011 -- At the Heart Failure Society of America's 15th Annual Scientific Meeting, Alan Maisel, M.D., VA San Diego Healthcare System, announced that B-type natriuretic peptide (BNP) may have utility in monitoring heart failure patients for early warning signs of decompensation in advance of acute presentations. HABIT, a multi-center study led by Maisel and sponsored by Alere Inc., is the first of its kind to have heart failure patients measure their BNP levels from home every day. 187 subjects were enrolled in the study following hospital discharge for a heart-failure-related event, and BNP levels were measured daily for 60 days using a fingerstick test run on the Alere™ Heart Check System. The results of the study demonstrate that BNP levels fluctuate rapidly and frequently in heart failure patients. They also provide insight into new strategies for monitoring these fluctuations, which in turn might lead to the early identification of problems in these patients. "The results of the HABIT study provide an important advancement in our knowledge about B-type natriuretic peptide in heart failure," said Maisel. "For the first time, we have seen that, in a population of patients discharged with heart failure, natriuretic peptides can rapidly and significantly change from day to day over the course of weeks, illustrating that frequent measurement could be useful in the accurate assessment of heart failure patient status." BNP is secreted by the heart's ventricles in response to changes in pressure that occur when heart failure develops or worsens. As the symptoms of heart failure become more severe, the level of BNP in the blood increases. For this reason, routine monitoring of BNP levels in outpatient and home settings may be a viable tool for identifying decompensation events earlier and managing them more effectively. The results of HABIT appear to support this conclusion. "The routine availability of BNP values in established heart failure patients could provide us with the first direct and objective indicator of the heart's response to change in a patient's condition," stated Maisel. "BNP could become an important monitoring tool for use in the homes of patients to manage the disease remotely, thereby identifying decompensation earlier to reduce healthcare costs and downstream re-hospitalizations."... [PDF] Alere's Press Release -