Meddevicetracker weekly round up 7th November

Absorb BVS Fails to meet Co-Primary Endpoints in Study Results at TCT

Three-year results from the ABSORB II Trial were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in the presentation titled "ABSORB II: Three-Year Clinical Outcomes From a Prospective, Randomized Trial of an Everolimus-Eluting Bioresorbable Vascular Scaffold vs an Everolimus-Eluting Metallic Stent in Patients With Coronary Artery Disease." The Absorb stent was assessed and compared to the results of the Xience everolimus-eluting stent. The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold.

See more information on ABSORB BVS on Meddevicetracker. 

Evolut R System Positive Data Presented at TCT

The Evolut R System FORWARD study marks the first time the system was evaluated in routine clinical practice on a global scale. Designed to confirm the exceptional results achieved in the Evolut R CE Study for patients with severe aortic stenosis, the FORWARD study demonstrated an exceptionally high survival (98 percent) and a low rate of all stroke (3 percent) at 30-days post-implant. The Recapturable CoreValve Evolut R System is similar to the CoreValve Evolut, with the main change being the way it interacts with the delivery system to make it recapturable. The CoreValve Evolut R consists of the CoreValve Evolut R transcatheter aortic self-expanding valve system and the EnVeo R Delivery Catheter System.

See more information on CoreValve Evolut R on Meddevicetracker.

 ChemBio’s Zika Virus Assay Gains Brazilian Approval

Chembio Diagnostics announced that it has received approval for commercial use of its DPP Zika IgM/IgG Assay by the Brazilian health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA). Chembio's DPP Zika IgM/IgG Assay detects antibodies using a tiny (10uL) drop of blood from the fingertip and provides semi-quantitative results in 15 minutes, using Chembio's patented DPP technology platform and handheld, battery-operated DPP Micro Reader.

See more information on DPP Zika Virus Assay on Meddevicetracker.

Favorable Results for St. Jude’s AMPLATZER Amulet LAA Occluder at TCT

Data regarding St. Jude Medical’s AMPLATZER Amulet LAA Occluder were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference, proving the device demonstrated high implant success and a strong safety profile. The AMPLATZER Amulet LAA Occluder is used to close the LAA (an appendage of the left atrium) in patients diagnosed with non-valvular AF. Other findings presented included a 99% closure rate at one to three month follow up and 2.7% of patients experienced acute device/procedure related major adverse events within seven days.

See more information on AMPLATZER Amulet LAA Occluder on Meddevicetracker.

 Optune Receives Positive Coverage Decision from United Healthcare

Novocure announced that United Healthcare will cover Optune as an adjunctive therapy for the treatment of glioblastoma (GBM) when used according to U.S. Food and Drug Administraion (FDA) labeled indications and contraindications, effective Jan. 1, 2017. As of Jan. 1, 2017, more than 177 million Americans will have coverage of Optune, a portable, noninvasive device that delivers Tumor Treating Fields (TTFields) therapy to patients with newly diagnosed and recurrent GBM. United Healthcare’s positive coverage policy of Optune adds to positive coverage policies from Harvard Pilgrim Healthcare, Oregon Health Plan and Blue Cross Blue Shield of Arizona.

See more information on Optune on Meddevicetracker.