• Amedica (Salt Lake City), an orthopedic implants company focused on silicon nitride ceramic technologies, said the FDA has granted a special 510(k) marketing clearance for the Valeo ceramic VBR spinal implant. The implant is intended for vertebral body replacement to aid in surgical correction and stabilization of the thoracolumbar spine. It incorporates Amedica’s silicon nitride ceramic, which provides new functionalities compared to other devices on the market. The implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion, for a prolonged period of time. “This is an important alternative to spine implants made from titanium and PEEK, as well as bone grafts taken from human cadavers,” said Darrel Brodke, MD, associate professor in the department of orthopedic surgery at the University of Utah School of Medicine and chief of the spine service and medical director of the University Spine Center.

• FlowCardia (Sunnyvale, California) reported FDA 510(k) clearance and immediate U.S. launch of the Crosser 14P, Crosser 14S and Crosser 18 CTO Recanalization Catheters. The three peripheral Crosser catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross chronic total occlusions (CTOs) to help restore blood flow to the lower legs. The Crosser is a rapid-exchange catheter delivered over standard .014” and .018” guidewires that utilizes high-frequency vibration to cross CTOs, allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral Crosser catheters were studied in the FlowCardia PATRIOT Trial. PATRIOT principal investigator Jim Joye said, “After completing the clinical trial, we are looking forward to using the Crosser in our daily practice. The device worked well in the upper leg and also proved an excellent primary therapy for crossing the more difficult, below the knee occlusions. This new endovascular line of catheters will help us cross lesions that previously could only be treated with a more invasive open surgery.”

• Theregen (San Francisco) has completed enrollment of its 15-patient Phase I safety trial for the Anginera epicardial patch on patients undergoing coronary arterial bypass graft surgery. The company said it intends to treat patients suffering from cardiac dysfunction who are undergoing surgery for a variety of reasons, including CAD and ischemia, heart valve disease or septal defects. In each of these populations, a portion of the heart is beating poorly, and Anginera has demonstrated an ability to improve both perfusion and regional ventricular wall function. In patients with ischemia and prior myocardial infarction or heart attack, this treatment may limit the area of heart muscle damage by providing better local perfusion. It may also awaken “hibernating myocardium” to improve ventricular wall function, and may not only improve function in the short term, but may prevent the progressive deterioration of function that leads to increasing heart failure. Theregen said it is “re-purposing” an existing FDA-approved device for cardiac applications.

• Vapotherm (Stevensville, Maryland) introduced a new respiratory care device. The Precision Flow is a high-flow therapy device that integrates humidification, gas blending, flow control and full alarm functionality into a single device for the delivery of nasal cannula inspired gases. “We developed Precision Flow with extensive input from our respiratory customers and we believe the device will meet their stated requirements for performance, safety and cost-effectiveness,” said Kevin Thibodeau, VP of sales and marketing.