Positive Results for Somahlution’s DuraGraft
Somahlution’s DuraGraft vascular graft treatment significantly improves long-term outcomes in coronary artery bypass grafting (CABG) surgery, the company said at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting.
DuraGraft treatment for 2,436 patients who underwent CABG surgery has shown a statistically significant reduction in risks for non-fatal myocardial infarction, repeat revascularization, and a composite of major adverse cardiac events.
DuraGraft is currently not available in the U.S. market.
J&J Warns Insulin Pump Users of Cyber Risk
Johnson & Johnson is warning patients of a small risk that hackers could target its Animas OneTouch Ping insulin pump, after learning of a bug causing a potential cybersecurity risk.
Jay Racliffe, a “white hat” hacker for J&J, discovered that hackers could break into the unencrypted communications between the Animas OneTouch Ping’s remote control and insulin pump, potentially forcing it to deliver unauthorized insulin doses.
St. Jude’s Spinal Stimulation Device Approved
The FDA approved St. Jude Medical’s BurstDR stimulation device, which is a physician-operated form of spinal cord stimulation (SCS) to provide relief for patients with chronic pain.
The device sends out intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.
Chronic pain affects approximately 1.5 billion people worldwide.
Xeltis Implants Pediatric Heart Valves
Xeltis has successfully implanted three pediatric patients with the first heart valve enabling cardiovascular restoration.
The patients have been enrolled in the “Xplore-I” clinical study of Xeltis bioabsorbable pulmonary heart valve, which is studied on patients from 2 to 21 years of age.
The Xeltis technology is an investigational device and is not yet approved for sale.
Elixirgen Launches Neuron Differentiation Kit
Elixirgen has launched its Quick-Muscle 1.0 kit, which develops skeletal muscle cells from human stem cells in just a few days.
The device kit promotes rapid and efficient production of skeletal muscle cells from human embryonic stem cells and induced pluripotent stem cells in only four to five days.
Quick-Muscle 1.0 is now available for purchase in the U.S.
Edwards Hypotension Indicator Gets CE Mark
Edwards Lifesciences received the EU CE Mark for its Acumen Hypotension Probability Indicator (HPI) that alerts clinicians to potential hypotension in surgical and critical care patients before it occurs.
HPI is compatible with Edwards’ minimally invasive, hemodynamic monitoring solutions. A targeted commercial release is planned for the device in Europe in 2016 and a full launch in 2017. It is not approved for commercial use in the U.S.