• AtriCure (West Chester, Ohio) reported that the first patient was successfully treated in AtriCure’s ABLATE clinical trial. The purpose of the ABLATE clinical trial is to evaluate the safety and effectiveness of AtriCure’s Isolator Synergy bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation (AF), requiring concomitant open-heart surgery using the Cox Maze IV procedure. The Isolator Synergy bipolar ablation system is designed to create precise lesions, or scars, on heart muscle, which block irregular electrical signals and restore normal sinus rhythm. AtriCure specializes in cardiac surgical ablation products.

• Covidien (Boulder, Colorado) reported the introduction of a new, continuous, positive airway pressure (CPAP) device with an integrated heated humidifier. The Sandman Intro CPAP device is designed for a broad range of patients and provides continuous positive airway pressure and heated humidification. Travel-friendly features include the ability to run on AC/DC or external battery power and an altitude compensation feature that automatically adjusts pressure up to 9,000 feet of elevation, and compensates for changes in barometric pressure to preserve a patient’s prescribed settings. Covidien makes CPAP and other sleep therapy devices and accessories.

• HealthSonix (Irvine, California) said that it is has approved the final sample of its second generation enSonix medical device. The enSonix personal treatment device has been indicated for pain reduction and muscle relaxation. “With this new medical device, we offer our customers affordable, effective arthritis pain relief without side effects. Patients can use it in the comfort of their own homes. The enSonix therapy is especially effective when used in combination with the most popular pain relievers. There is an incremental therapeutic benefit when you combine therapies,” said Dieter Doederlein, VP of corporate development. The sound pressure waves generated by the enSonix medical device are believed to work in three ways: they stimulate mechanoreceptors in the skin, which in turn communicate with the brain and block pain messages from getting through (the gate control theory of pain); they create an exercise effect in the muscles, which encourages the production and release of endorphins, the body’s natural pain killers; and increase in blood circulation. HealthSonix makes products that deliver sound pressure waves to the human body for relief of pain and other musculoskeletal conditions.

• HepaLife Technologies (Boston) reported results from new in vitro studies in which the company’s patented PICM-19 liver stem cells were placed inside its proprietary bioartificial liver device and were able to successfully and quickly remove high levels of toxic ammonia within a very short period of time. When challenged with high amounts of toxic ammonia, present in patients with acute liver failure, HepaLife’s bioartificial liver reduced ammonia levels by 75% within less than 24 hours. Published in vivo clinical data of other systems using liver cells other than HepaLife’s patented PICM-19, have only reported ammonia reduction levels from zero percent to 44%. During these same tests HepaLife’s PICM-19 liver stem cells inside the company’s bioartificial liver maintained differentiated hepatic (liver) function, showing typical hepatocyte morphology — the characteristics representative of human liver cells — including cell features such as intercellular canaliculi, extensive Golgi apparatus, endoplasmic reticulum, peroxisomes and mitochondria. HepaLife makes cell-based medical technologies addressing prevalent human health concerns.