Myriad's BRACAnalysis CDx Test Identifies Patients with Ovarian Cancer Who Would Benefit from Second-Line Maintenance Treatment with Olaparib
Myriad announced results of the SOLO2 clinical trial, a Phase III clinical trial that included the BRACANAlysis CDx test as a diagnostic with olaparib, and oral PARP inhibitor being developed by AztraZeneca.
SOLO2 compared maintenance olaparib against placebo in patients with platinum-sensitive relapsed ovarian cancer. In this study, patients were tested for germline BRCA (gBRAC+) mutations as determined by Myriad's BRACAnalysis CDx test.
The results showed that the olaparib-treated patients achieved the primary endpoint of prolonged PFS and that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
See more on the BRACAnalysis Companion Diagnostic on Meddevicetracker.
Teleflex Announces European Market Clearance for its Arrow VPS Rhythm System
Teleflex has announced that its Arrow VPS Rhythm System has been issued CE certification from its notified body, the British Standards Institution (BSI), to commercialize the device in the European Union.
The Arrow VPS Rhythm System with ECG Technology assists in placement and confirmation of the catheter tip in the SVC-CAJ (superior vena cava-cavoatrial junction), and may be used with a broad range of catheter types. When paired with the single-use TipTracker Stylet, the Arrow VPS Rhythm System provides real-time navigation, tracing the catheter pathway with a visible blue line on a color screen. Intravascular P-wave changes are saved as the catheter approaches the SVC, helping to identify the lower 1/3 of the SVC, near the CAJ, eliminating the need for confirmatory chest X-ray or fluoroscopy.
See more on ARROW VPS Rhythm on Meddevicetracker.
Abiomed Receives FDA IDE Approval for Initiation of Door to Unloading (DTU) Prospective Feasibility Study
Abiomed announced that it received Investigational Device Exemption (IDE) approval from the FDA of a prospective feasibility study to evaluate the use of the Impella CP heart pump for unloading of the left ventricle prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction (STEMI), without cardiogenic shock.
The study, "Door to Unloading (DTU) with Impella CP System in Acute Myocardial Infarction to Reduce Infarct Size," is a prospective, multi-center feasibility study that will include up to 50 patients at 10 sites and is expected to initiate in the first half of calendar 2017 and be completed within 18 months.
See more on Impella CP on Meddevicetracker.
Cepheid announces CE Mark of Xpert Xpress Flu/RSV Test
Cepheid announced that the Xpert Xpress Flu/RSV test is available in the EU and all countries recognizing the CE-Mark. Xpert Xpress Flu/RSV is twice as fast as its predecessor (Xpert Flu/RSV CXC) with comparable performance characteristics. Cepheid said this assay is the first in a series of tests from the company that will deliver results in 30 minutes or less.
See more on Xpert Xpress Flu/RSV on Meddevicetracker.
NeuroMetrix Announces Issuance of New U.S. Patent for Quell Wearable Pain Relief Technology
NeuroMetrix announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,474,898. The patent covers key technology that enables safe delivery of Quell therapy for chronic pain while the user is sleeping. Over 80% of chronic pain sufferers report low quality sleep, which then further exacerbates pain. Quell is the only high intensity transcutaneous electrical nerve stimulator cleared by the FDA for use while sleeping.
See more on Quell on Meddevicetracker.