Surgical Product News

Surgeons add ablation in the Cox-Maze procedure

According to a report by heart surgeons at Washington University School of Medicine in St. Louis, the addition of one ablation in a series of ablations in the Cox-Maze procedure led to a substantial improvement in the atrial fibrillation surgical treatment outcome. Atrial fibrillation is the most common irregular heart rhythm condition that affects over two million patients in the US.

Zimmer recalls surgical support accessories produced at Dover plant

ZimmerZimmer Holdings Inc., an orthopedic implant maker, has temporarily recalled and suspended production of several surgical support accessories produced at its Dover, Ohio, facility. This company expects this move to result in lost revenues of $70-$80 million. The recall was initiated after the products failed to meet internal quality standards during the quality systems review at the Ohio site, the company said.

Atrium Medical receives FDA nod for two new Omega 3 surgical mesh products

C-QURAtrium Medical Corporation has obtained FDA 510(K) approval for two new Omega 3 surgical mesh products; C-QUR Edge V-Patch and C-QUR Lite V-Patch. These new products are indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair. This novel technology combines Atrium’s ProLite Ultra(TM) polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable gel coating.

St Jude Medical receives FDA and CE Mark approval for Strada Carotid Guiding Sheath

StradaSt. Jude Medical Inc.has received approval from U.S. Food and Drug Administration (FDA) and European CE Mark for its Strada Carotid Guiding Sheath. The equipment is a flexible tube available in 80 and 90 cm working lengths through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.

Covidien receives FDA nod for surgery kit for laparoscopic procedures

CovidienCovidien Ltd. has received approval from the FDA to market a surgery kit for use in laparoscopic procedures. Covidien’s SILS Procedure Kits can be used by surgeons to perform the procedures through a single incision through a patient’s belly button. The kit is set for launch this summer.

Arbios Systems receives FDA approval to start clinical trials for liver-assist device

ArbiosArbios 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 receives FDA nod for infusion catheter

ClariVeinVascular 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.

New surgical device saving lives in Iraq’s war zone

SoldierAn 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 launches FOOTPRINT PK Suture Anchor

Smith & Nephew LogoSmith & 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.

Integra launches new product in CSF drainage product line

Intrgra LogoIntegra LifeSciences is marketing its LimiTorr Volume Limiting CSF Drainage System as the latest addition to its cerebral spinal fluid (CSF) drainage product line, which helps manage the intracranial pressure of a neuro-compromised patient or a patient undergoing abdominal aortic aneurysm surgery. The system can be used for lumbar and ventricular drainage and includes a volume-limiting valve mechanism which halts drainage when the pre-determined volume of 20 mL or 30 mL is met.

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