Proving efficacy of a surgical sealant in GI anastomosis is likely to be difficult, but Cohera hopes its Sylys IDE will hit the spot.
Gastroenterology
FDA Clears Aer-O-Scope™ 360° Colonoscope System
GI View Ltd., has announced that it has received U.S. FDA 510(k) clearance for its flagship product, the Aer-O-Scope™ Colonoscope System
EndoBarrier® Back on EU Market, with Revised IFU
It seems the suspension of EndoBarrier sales in Europe it was more than just a paper exercise, as vigilance changes have seen it change its indications.
Cardica Calls Time-Out to Re-Think MicroCutter XCHANGE 30®
Cardica, Inc. is to pull the remainder of the latest iteration of its MicroCutter XCHANGE 30® from sale, drawing a line under the device until a next generation version is ready.
Notified Body Orders Suspension of Endobarrier Shipments in Europe
GI Dynamics, Inc., developer of EndoBarrier® for treatment of obesity and type 2 diabetes, has seen its product suspended and announced falling sales.
EndoGastric’s TIF Procedure Outperforms PPI in Controlling GERD Symptoms
One-year results of the TEMPO trial demonstrate that the Transoral Incisionless Fundoplication (TIF®) procedure achieved sustained elimination of all GERD symptoms and healing of esophagitis.
Torax Medical’s Linx® GERD Device Looking Good at 5 Years
Torax Medical is reporting the approaching completion of 5 year data collection in the clinical trial for the LINX procedure.
MUSE™ Prospective Study Points to Success in GERD Treatment
85% of patients reduced medication use following the MUSE minimally-invasive procedure for GERD, with 65% eliminating medication entirely after 6 months
Ethicon Unveils Expanded Bariatric Surgery Portfolio at IFSO 2014
Ethicon is introducing three new endocutter and energy products at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014).
New Study Says Stretta is Valuable GERD Treatment
A newly published peer-reviewed paper concludes that Mederi Therapeutics’ Stretta therapy is a safe, effective and durable treatment for gastro esophageal reflux disease.
VBLOC® Vagal Blocking Obesity Therapy Would be First for Ten Years… if Approved
If FDA supports its advisory panel’s less than unanimous endorsement, EnteroMedics’ VBLOC will be the first device to be approved for Obesity treatment in ten years.
New EndoBarrier® Data Informs on Glycemic Control and Obesity
New data further demonstrate the acute effects of EndoBarrier® Therapy on glycemic control, its ability to reduce reliance on diabetes medications and potential mechanism of action.
Registry Data Points to Success Predictors for GERD Treatment
U.S Registry data suggests that GERD treatment using EndoGastric Solutions’ TIF procedure will be successful in patients with persistent symptoms despite use of PPI therapy.
Ethicon’s HARMONIC ACE®+7 Shears Have LigaSure™in Sights
Ethicon Endo-Surgery has launched its HARMONIC ACE®+7 Shears with Advanced Hemostasis, the first purely ultrasonic device with a 7 mm sealing indication. It claims the system outperforms its rival LigaSure™device when it comes to burst pressure.
Could there be a First Bowel Anastomosis Sealant on Horizon?
Surgical adhesive specialist Cohera Medical, Inc.®, has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures. The company says approval is expected by the end of 2014.
Prep-Less Colon Imaging Capsule Aims to Improve Screening Compliance
A new “swallowable” GI imaging device device has the potential to safely produce high-resolution images of the colon without requiring patients to go through the bowel cleansing process beforehand, says data presented at a research forum during DDW2014.