General Surgery

Ethicon endo’s voluntary recall of certain Proximate Circular staplers during the summer has turned in to an FDA Class I recall due to the serious consequences that can befall the patient in whom the stapler has not completely fired.

Insightra Medical has announced that its new Freedom inguinal hernia system has been cleared by the FDA. The device aims to address post-op chronic pain associated with traditional meshes by avoiding rigid fixation.

Capsule endoscopy company Given Imaging Ltd. has acquired from The SmartPill Corporation, a U.S. based-company, the assets related to the SmartPill® GI Monitoring System for $6 million including earn-outs based on revenue between now and 2016.

Given Imaging Ltd. developer of the Pillcam Colon 2 swallowable camera system for visualisation of the colorectal lining, has submitted compelling trial data to the Japanese authorities showing that 94% of polyps identified using standard colonoscopy were also spotted by its device.

Surgical Innovations has issued its 6 month financials which suggest the company has plenty of reasons to be cheerful as it looks forward to the fruits of new product approvals and distribution agreements in the U.S.

Covidien says its newly FDA cleared device is the world’s only fully powered reusable surgical EndoStapling platform and claims it sets new standards in precision during surgery.

Ageing population, improved screening and new treatments will drive GI Endoscopy market in U.S.A

GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

Covidien has announced that it is not only recalling all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU), but is in fact discontinuing the products.

EndoStim B.V. has announced CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter muscle.

Are the summer doldrums a good time to bury bad news or an opportunity to get your story to the top of the editor’s “hmmm interesting” list? We ponder this and other matters in our weekly View From The Med.

J&J subsidiary business Ethicon Endosurgery has issued a voluntary recall of certain lots of its PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories. The recall was provoked by reports of difficulty firing the device although the company seems to have no problem doing so when reloading returned devices.

Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its HARMONIC ACE®+ Shears with Adaptive Tissue Technology. The company says this represents the next generation in its “best-in-class” HARMONIC® portfolio of ultrasonic surgical devices that can handle multiple surgical jobs.

Hill-Rom has completed its acquisition of Aspen Surgical Holdings in a move which the Batesville, Indiana outfit believes will enhance its presence in the surgical products market.

Xlumena, Inc. has announced that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts.

Steris Corporation is to acquire United States Endoscopy Group, Inc. and in so doing significantly expand its presence in the gastrointestinal(GI) procedural market with a franchise of proprietary, single-use consumable medical devices.