Cath Lab Digest

Witt Biomedical and GEMMS Announce Marketing and Technology Partnership

New Alliance Establishes a Continuum of Care between the Hospital and Ambulatory Cardiology Practice

Witt Biomedical, focusing on cardiovascular enterprise technology, and GEMMS, developer of a fully integrated, cardiology-specific electronic clinical information system, announced a marketing and technology partnership to benefit cardiovascular physicians and patients. Witt and GEMMS will discuss the advantages of the new partnership at ACC 2006.

According to Witt Biomedical President Mike Wolfe and GEMMS CEO Rodger P. Pinto, PhD, the alliance presents a unique opportunity for the two companies to create a continuum of care between cardiovascular testing and treatment in the hospital and care provided in the physician practice.

Wolfe explained, Our technologies complement each other in ways that will directly enhance workflow for cardiologists. GEMMS’ single-point decision system in the ambulatory cardiology practice, GEMMS|One, will provide Witt’s cardiovascular enterprise system in the hospital with the patient’s history and procedures, verification of medical necessity, and other information required to create a comprehensive record. In turn, Witt will close the loop by sending the findings of studies, tests and therapies, the transcription report, discreet data, and other pertinent details to GEMMS|One.

Pinto agreed, noting, By sharing information and seamlessly integrating our technologies, we can achieve our shared vision to provide cardiologists with complete access to critical patient information, ranging from the office visit to non-invasive cardiovascular testing to the cath lab and back to the physician practice. This holistic view of each patient’s case will empower the cardiologist to make faster, more confident diagnoses and decisions."

Janus Tacrolimus-Eluting Carbostent Demonstrates Excellent Safety Profile and Clinical Efficacy

First Six-month Clinical Findings from e-Janus Registry Presented at JIM Congress in Rome

Sorin Group, Europe's largest medical technology company specializing in the treatment of cardiovascular diseases, presented the first six-month clinical results from its e-Janus international "real-world" registry. The data, presented at the Joint Interventional Meeting (JIM) in Rome on February 17, 2006, confirm that the Janus Tacrolimus-eluting Carbostent provides an excellent safety profile and clinical efficacy for the treatment of "real-world" patients, including the high-risk AMI (acute myocardial infarction) patient population.

While still recruiting, the e-Janus registry has currently enrolled over 2500 patients at more than 80 centers worldwide (except the U.S. and Japan). Six-month clinical follow-up on 587 patients were presented by Dr. J. Koolen (Eindhoven, The Netherlands), the Principal Investigator (PI) of the study.

In the overall population analyzed (587 patients), Dr. Koolen reported a 4.3% major adverse cardiac events (MACE) rate and a 3.1% target lesion revascularization (TLR). MACE includes death, myocardial infarction (MI; Q-wave and non-Q-wave) and target lesion revascularization.

Out of the 587 patients who had completed the six-month follow-up, 31% were diabetic patients, 50.4% were patients with multi-vessel disease and 23% percent of patients presented with an acute myocardial infarction.

Dr. Koolen highlighted the results achieved in the AMI patient subset, with a 3.0% MACE rate at six-month follow-up. In these 133 AMI patients, the TLR rate was 2.2% and, more importantly, the late stent thrombosis rate for this high risk subgroup was 0%.

e-Janus is a multi-center, prospective registry, designed to collect real-world clinical outcomes in more than 2500 patients with coronary artery disease at more than 100 centers worldwide, except the U.S. and Japan. e-Janus is based on electronic CRFs, with a 3% site monitoring and with an independent CEC (Clinical Events Committee) reviewing and adjudicating adverse events.

OmniSonic's Resolution® Endovascular System Transitions to Full U.S. Market Release

OmniSonics Medical Technologies, Inc. announced that it has transitioned to a full U.S. market release of the Resolution® Endovascular System. The full market release follows the completion of a limited release that commenced upon FDA clearance in December 2005 for use in the treatment of thrombosed, synthetic dialysis access grafts. OmniSonics has initiated the expansion of the treatment of patients at additional healthcare facilities and will continue to roll out the Resolution Endovascular System as the Company's sales and operations infrastructures expand.

In occlusions that varied in age from several weeks to three months, the Resolution Endovascular System consistently re-established flow and resolved the clot in less than six minutes of application time. In addition to clearing aged-mature thrombus, physicians reported successful clot resolution and flow restoration in procedures where the patient was referred for treatment after having previously failed treatment utilizing another percutaneous thrombectomy technique.