General Surgery

Flexible Stenting Solutions inc., has announced receipt of FDA 510(k) clearance for an increased range of sizes of its FlexStent® Biliary Self-Expanding Stent System, including 9 and 10 mm diameters in lengths up to 100 mm.

Cook Medical has gained 510(k) clearance for its Evolution® Colonic Controlled-Release Stent. The new stent is used to palliate uncomfortable symptoms associated with colonic obstructions caused by malignant neoplasms and relieve large-bowel obstructions prior to colectomy procedures.

FDA has cleared ProPep’s Nerve Monitoring System, the first real-time nerve monitoring system specifically designed for use during robotic surgery.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.

Surgical Innovations Group plc, and CareFusion Inc. have agreed an eight year exclusive US distribution agreement for SI’s clever PretzelFlex® laparoscopic retractor.

More clinical evidence, presented last week, supports GI Dynamics’ case that its EndoBarrier® gastrointestinal lining device represents an effective therapeutic option in overweight and mildly obese type II diabetic patients.

Covidien’s V-Loc™ knotless suture has now been combined with its endoscopic suturing devices with claimed significant time saving for surgeons.

Leeds, UK-based Surgical Innovations has renewed its UK distribution arrangement with the signing of a 5 year distribution deal with Elemental Healthcare.

Covidien says its new Radial Reload allows surgeons to cut and securely staple colon tissue up to 2 cm deeper into the pelvis than the Ethicon Contour® Curved Cutter Stapler.

ConvaTec has followed up its May announcement of the acquisition of AbViser Medical, LLC with the news that its ostomy systems range is to expand with the acquisition of UK company Trio Healthcare International Ltd.

Boston Scientific Corporation has announced the FDA clearance for an expanded use indication for the CRE™ Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy, quite literally opening up the possibility of using it for dilation assisted stone removal.

Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.

Covidien has unveiled its new range add HALO 90 ULTRA for ablative treatment of large Barrett’s Oesophagus lesions. The device, which comes from the stable of recently acquired Barrx Medical, is double the length of its HALO 90 brother and as such can reduce ablation treatment time and in so doing shorten the procedure.

Laparoscopic surgery instruments may need to be larger than the access portal through which they are delivered, which means some degree of internal assembly could open up possibilities for more useful devices. Now the way is clear as FDA issues its first such clearance.

Millennium Research Group believes strong growth in Radioembolization Spheres, Drug-Eluting Beads and Flow-Diverting Devices will result in a 5.5% annual market growth rate through 2016.

Not many weeks go by without news of a Covidien acquisition, so its not too surprising when the tech titan takes a shine to a company who’s product can help place its hernia meshes in a speedy and effective fashion.