Approvals

FDA Clears Roche Diagnostic for Non-Small Cell Lung Cancer

Roche received FDA clearance for the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia.

The assay detects the anaplastic lymphoma kinase protein in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue stained with a BenchMark XT or BenchMark Ultra automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with Xalkori or Zykadia.

Cardiac Troponin Test Receives CE Mark

Singulex has received the CE Mark for its Singulex Sgx Clarity cTnl assay for the biomarker troponin.

The assay is indicated for use in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease. The company will submit data for FDA clearance of the assay in 2018.

Medovex Wins CE Mark for DenerveX System

Medovex Corp. has received a CE Mark for the DenerveX system.

The system consists of a single-use medical device kit and the DenerveX Pro-40 power generator. The device’s slowly rotating burr removes targeted facet joint synovial membrane and joint surface while heat ablation destroys tissue and removes residual nervous and synovial membrane overlying the joint. The system is not yet FDA cleared.

Claret Medical Gains FDA Clearance for Its Sentinel Cerebral Protection System

Claret Medical has received de novo clearance from the FDA for the Sentinel cerebral protection system.

The device removes debris dislodged during transcatheter aortic valve replacement before it reaches the brain. In a clinical trial, use of Sentinel reduced strokes by 63 percent in the first 72 hours after TAVR and maintained a substantial difference at 90 days.

FDA Approves Expanded Indication for Sapien 3 Heart Valve

Edwards Lifesciences’ Sapien 3 THV artificial heart valve received FDA clearance for an expanded indication to include treatment for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve.

Valve-in-valve procedures offer an alternative to repeat surgery, since the replacement valve is inserted inside the failing surgical bioprosthetic valve through a blood vessel or a small cut in the chest.

Boston Scientific Wins CE Mark for Deep Brain Stimulation System

The European Commission has awarded Boston Scientific a CE Mark for the Vercise primary cell deep brain stimulation system.

The system provides precise neural targeting for patients suffering from Parkinson’s disease, primary and secondary dystonia and essential tremor. It is not available for use or sale in the United States.