Cardica (Redwood City, California) has received FDA 510(k) clearance to market its C-Port xA Distal Anastomosis System in the U.S. The system automates the creation of anastomoses, or attachments of blood vessels and grafts, such as those in coronary artery bypass graft (CABG) surgeries. The system is designed to deploy staples around the periphery of the anastomosis to help provide leak-proof sealing. Other features include improved access to the coronary artery and reduction of target site preparation; optimization of the staple configuration; and incorporation of vessel clamps for ease of loading the graft vessel for anastomosis. The C-Port xA system received the CE mark in July 2006 and is currently marketed in Europe. Cardica designs and manufactures automated anastomosis systems for CABG surgery.

• CryoCath (Montreal) has received notification from the FDA allowing the company to expand its pivotal investigational device (IDE) STOP AF trial. The company can now enroll up to 150 patients in up to 20 centers. To date, five centers have received Internal Review Board (IRB) approval and have begun screening patients, including 16 that have already been enrolled and randomized. As many as 250 patients, randomized into two arms, will be enrolled to complete the trial. One cohort will receive cryoablation therapy with Arctic Front (the ablation arm); the other will receive currently prescribed drug therapies (the control arm). For every two patients in the ablation arm, there will be one in the control arm. Patients in the trial will be highly symptomatic paroxysmal atrial fibrillation (AF) patients who have failed at least one anti-arrhythmic drug. The trial’s primary endpoint will be the absence of detectable AF at the end of the 12-month follow-up period. The trial’s design also allows patients randomized into the drug arm to cross over into the ablation arm if they do not show improvement. Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat AF. This bi-directional, double balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Approved in Europe, it has treated more than 300 patients in more than 18 centers. CryoCath makes cryotherapy products to treat cardiovascular disease.

• CryoCor (San Diego) has filed a pre-market approval application (PMA) for the treatment of atrial flutter (AFL). CryoCor said it has developed a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The Cryoablation System, or the Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. In the United States, CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the Cryoablation System for the treatment of AF, and has submitted a PMA for the treatment of AFL. CryoCor is a medical device company focused on the treatment of cardiac arrhythmias.

• Thinking Systems (St. Petersburg, Florida) reported the release of its new version of its flagship ThinkingPACS with enhanced support for PET-CT fusion. According to the company, ThinkingPACS is known for its comprehensive modality support with cutting-edge technologies, such as PET-CT and SPECT-CT fusion, nuclear cardiology processing and analysis, general nuclear medicine processing and review, cardiac PET analysis, PET brain analysis, 3D/MPR, calcium scoring, cardiac CTA, cardiac cath, echocardiography, general ultrasound, orthopedic templating, mammography, and connectivity to modalities, in addition to the conventional radiological CT, MR, and CR/DR imaging functionalities. Thinking Systems develops medical software.

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