Cardica (Redwood City, California) reported completing enrollment of about 220 patients in a pivotal clinical trial in U.S. and Europe to evaluate safety/efficacy of its PAS-Port Proximal Anastomosis System during coronary artery bypass graft (CABG) surgery. The PAS-Port system, commercially available in Japan and Europe, creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during bypass procedures, Cardica said. The trial is being conducted in the U.S. under an Investigational Device Exemption. Two venous bypass grafts were randomly selected in each patient to be connected to the aorta using either the PAS-Port device or the conventional hand-sewn technique. Patients will receive a follow-up angiogram nine months after their procedure to determine patency (degree of openness of the vein graft) of both PAS-Port and control grafts. If the results of this trial are favorable, the company plans to submit a 510(k) application for the PAS-Port system to the FDA in early 2008. The PAS-Port system is designed to allow the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in about two minutes, with little or no injury to the bypass graft vessel or the aorta. Cardica makes automated anastomosis systems for coronary artery bypass graft (CABG) surgery.

CryoCath Technologies (Montreal) said it has received FDA approval to expand its pivotal Investigational Device Exemption STOP AF trial for Arctic Front to the full cohort of patients in all 20 centers. The trial is designed to demonstrate Arctic Front's clinical and therapeutic effectiveness in treating paroxysmal Atrial Fibrillation (AF) when compared to traditional medical therapy. CryoCath develops cryotherapy products to treat cardiovascular disease.

Ingenuity Systems (Redwood City, California) has launched IPA-Tox, a pathways-driven molecular toxicology solution designed to enable researchers to understand safety issues associated with new drug candidates. Ingenuity Pathways Analysis 5.0 (IPA) is a software application intended to enable researchers to model, analyze, and understand the complex biological systems at the core of life science research. IPA is deployed in all major pharmaceutical companies and hundreds of biotechnology companies and academic institutions globally. It supports analysis of all experimental platforms, and is used at all stages of the drug discovery and development process, from target identification and validation to identification of biomarkers, predictive toxicology, and pharmacogenomics, the company said. Ingenuity products include pathways analysis software and knowledge bases for biologists and bioinformaticians, and enterprise knowledge management infrastructure, content and services for leading pharmaceutical and biotech companies.