Arbios Systems Inc. has received approval from the FDA for an investigational device exemption to begin the pivotal clinical trial for its liver-assist device, SEPET, for purifying blood in acutely ill patients with chronic liver disease. When a patient’s blood is passed through the device containing microporous, hollow fibers, blood plasma components are cleansed of harmful impurities. These impurities would otherwise accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing the risk of sepsis development and accelerating damage to the liver, lungs and other organs.

Vascular Insights LLC has achieved 510(k) clearance from the FDA to market its ClariVein infusion catheter. The catheter infuses physician-specified agents in the peripheral vasculature. It contains a rotating wire driven by a motor that enhances fluid dispersion in the treatment area.

An independent clinical study conducted by the U.S. Army combat support surgeons in Baghdad shows that a new medical device used to close a type of surgical wound more quickly is saving lives and limbs of soldiers and civilians. A team of battle zone surgeons, led by Maj. Niten Singh, used Canica Design Inc.’s ABRA(R) Surgical Skin Closure System to successfully implement a new surgical regimen called dynamic wound closure (DWC). Dr. Singh said that the use of Canica’s system enabled them to close fasciotomies in an average 2.6 days, several times faster than other techniques.

Smith & Nephew’s Endoscopy Division announced the launch of the FOOTPRINT PK Suture Anchor, a system used to attach rotator cuff tissue to bone in the shoulder. The system delivers a Transosseous Equivalent (TOE) repair without the need for drilling transosseous bone tunnels.