• AtriCure (West Chester, Ohio) reported that its Isolator bipolar ablation clamp system has received FDA clearance for the ablation of cardiac tissue. AtriCure believes that theirs is the only bipolar radio frequency clamp system that has been cleared by the FDA for the ablation of cardiac tissue. "The AtriCure team is pleased to have achieved this major milestone. This expanded indication reaffirms our leadership position in our rapidly growing markets," said David Drachman, president/CEO. "Furthermore, we continue to make significant progress toward obtaining an atrial fibrillation indication for our Isolator ablation clamp and pen systems. We look forward to continuing to make important contributions toward improving and preserving human life." AtriCure makes cardiac surgical devices designed to create precise lesions, or scars, in soft and cardiac tissues.

A non-randomized, controlled study, led by Jon Matsumura, MD, generated positive results on the Cook Zenith TX2 thoracic aortic aneurysm (TAA) endovascular graft for thoracic endovascular aortic repair (TEVAR), Cook Medical (Bloomington, Indiana) reported. The trial results indicated that the TEVAR procedure, using the Cook Zenith TX2, is a promising alternative to open surgical repair for the treatment of TAAs. Matsumura and colleagues presented data which included primary endpoints for 30-day survival and 30-day rupture-free survival, comparing the minimally-invasive TEVAR procedure using Cook's TX2 device to a control group that underwent open surgical repair for their thoracic aneurysms. Matsumura reported that the 30-day survival rate for patients in the test group who received the Cook graft was similar to the open surgery group. The Zenith patients experienced no ruptures or conversions in the first year. The Zenith TX2 device is deployed from a catheter inserted through a small incision in the patient's femoral artery, eliminating the need for invasive open surgery to open the chest, clamp off and remove the diseased section of the aorta, and replace it with a surgical graft. Post-operative and post-discharge recovery times are typically shorter with TEVAR which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery. Cook Medical participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech.

• Correlagen Diagnostics (Waltham, Massachusetts) reported that it is offering a genetic test for hypertrophic cardiomyopathy (HCM). HCM is the leading cause of sudden cardiac death in children and young adults and accounts for 40% of all deaths on athletic playing fields across the U.S. HCM, which is characterized by a thickening of the heart muscle, is caused by a defect in one of several genes and can lead to severe problems including heart failure, stroke, or sudden death. While there is no cure for HCM, early diagnosis allows timely initiation of lifestyle changes and medical interventions that can delay disease progression and reduce the risk of sudden cardiac death. Many HCM patients benefit from beta blockers, calcium channel blockers and implantable cardioverter-defibrillators or ICDs. Since HCM is an inherited disease, it can be diagnosed through genetic testing, which can confirm a diagnosis in patients with unclear symptoms. Correlagen Diagnostics' HCM sequencing test requires only a cheek swab or a small blood sample from the patient. Physicians send the sample and the completed medical and insurance forms directly to Correlagen, where the patient's DNA is extracted and analyzed. Correlagen's automated testing processes allow for detection of disease-causing mutations in the genes known to be associated with most cases of familial HCM. Mutations detected in the genes are evaluated in the context of the current scientific literature, and a comprehensive report is prepared to help a patient'sphysician understand and explain the results of DNA sequencing to the patient. Correlagen Diagnostics makes genetic testing services.