Meddevicetracker weekly round up 24th October

 Svelte Medical Systems Announces CE Mark for DIRECT RX

Svelte Medical Systems announced it received CE Mark certification of the DIRECT Sirolimus-Eluting Coronary Stent Rapid-Exchange (RX) System for the treatment of coronary artery disease. The first patient to receive DIRECT RX was treated by Auke Weevers, MD, a practicing interventional cardiologist at Albert Schweitzer Ziekenhuis in Dordrecht, The Netherlands.

Svelte also announced that Svelte said that both of its stent platforms, SLENDER IDS and DIRECT RX, will be evaluated in the large, randomized, controlled, multi-center OPTIMIZE study, which is expected to commence next year in support of commercial approvals in the US and Japan.

See more on the DIRECT RX Drug-Eluting Stent on Meddevicetracker.

Tandem Diabetes Care Now Shipping Next-Generation t:slim X2 Insulin Pump

Tandem Diabetes Care announced commencement of shipments for its next-generation t:slim X2 Insulin Pump. The t:slim X2 Pump is designed with a Bluetooth radio and is optimized for use with Tandem’s Tandem Device Updater, cleared in July 2016. The updater is designed to update software and add new features from a personal computer as they are approved by the U.S. Food and Drug Administration (FDA). The t:slim X2 is replacing Tandem’s original t:slim insulin pump.

See more on the t:slim X2 Insulin Pump on Meddevicetracker.

Myriad RBM Announces an Agreement with Sanofi to Measure Predictive Cardiovascular Biomarkers in Patients with Diabetes

Myriad RBM announced that it will work with Sanofi to perform a biomarker analysis of blood samples from the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial for the drug Adlyxin.

Under the agreement, Sanofi will provide approximately 5,300 serum samples from the ELIXA trial. Myriad RBM will use its DiscoveryMAP/CustomMAP platform to measure biomarkers that can predict cardiovascular and microvascular (renal and retinal) risk in people with Type II diabetes. Financial terms of the deal were not disclosed.

See more on DiscoveryMAP on Meddevicetracker.

Second Sight Announces Successful Implantation and Activation of Wireless Visual Cortical Stimulator in First Human Subject

Second Sight Medical announced the first successful implantation and activation of a wireless visual cortical stimulator in a human subject, providing the initial human proof of concept for the ongoing development of the Company's Orion I Visual Cortical Prosthesis (Orion I).

In the UCLA study supported by Second Sight, a 30 year old patient was implanted with a wireless multichannel neurostimulation system on the visual cortex and was able to perceive and localize individual phosphenes or spots of light with no significant adverse side effects. The initial success of this study, coupled with the significant additional pre-clinical work gathered to-date readies Second Sight to submit an application to the FDA in early 2017 to gain approval for conducting an initial clinical trial of the complete Orion I system, including the camera and glasses. Assuming positive initial results in patients and discussions with regulators, an expanded pivotal clinical trial for global market approvals is then planned.

See more on Orion I on Meddevicetracker.

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.