February 20, 2017
Cardiovascular Systems (CSI) released 1-year results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at the 2017 Cardiovascular Research Technologies (CRT) conference. The COAST study is CSI’s global IDE trial to evaluate the safety and efficacy of the company’s next-generation Micro Crown orbital atherectomy technology in treating patients with severely calcified coronary lesions.
The 1-year results from the COAST IDE Study resulted in 77.8% freedom from 1-year MACE, therefore concluding that the Diamondback 360° Coronary OAS Micro Crown technology may address the unmet treatment need for this difficult to treat population.
See more information the Micro Crown OAS on Meddevicetracker.
Caris Life Sciences Announce Publication of New Data on ADAPT Platform
Caris Life Sciences announced the results of a study that demonstrates the ability of the company’s ADAPT Biotargeting System to detect and classify women with or without breast cancer based on a minimally-invasive liquid biopsy of circulating exosomes from blood plasma. The study was published in Nature’s Scientific Reports.
Results showed that Aptamer-mediated affinity purification and mass spectrometry identified low-abundance exosome-associated proteins and protein complexes associated with the two groups. A blinded evaluation of 500 samples from healthy women and breast cancer-positive patients distinguished the two groups independent of breast tissue density.
See more information the ADAPT Biotargeting System on Meddevicetracker.
February 21, 2017
Actamax Surgical Materials submitted an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) to study the Actamax Adhesion Barrier in a prospective, randomized controlled trial in gynecological laparoscopic surgery. In pre-submission meetings, Actamax worked constructively with the FDA to discuss questions and concerns and has used FDA’s feedback to determine path forward for its IDE application.
See more information the LABS Adhesion Barrier on Meddevicetracker.
Interpace Diagnostics Collaborates with Viatar CTC Solutions
Interpace Diagnostics announced the initiation of a collaborative research program with Viatar CTC Solutions Inc. The collaboration utilizes Viatar's novel circulating tumor cell collection technology in combination with the Company's commercialized PancraGEN assay that is used to help assess indeterminate pancreatic cancer biopsies in patients with pancreatic cysts. Studies are being designed to identify patients most likely to develop pancreatic cancer in the near future as well as to detect pancreatic cancer at its earliest stage of development. These pre-clinical studies are expected to take place over the next six months.
See more information on the PancraGEN and Viatar CTC Solutions on Meddevicetracker.
DiaSorin Announced U.S. Approval and Launch of Simplexa C. difficle Assay
DiaSorin announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) and launch of the Simplexa C. difficile Direct Assay for detection of Clostridium difficile (C. difficile). The assay is a scalable small bench-top instrument able to provide reliable, clinically validated, real-time PCR results for quantitative, qualitative, multi-analyte and sample-to-answer detection needs.
The Simplexa C. difficile assay was launched outside the U.S. in November 2016.
See more information on the Simplexa C. difficile Direct Assay on Meddevicetracker.
February 22, 2017
Bioness Announces European Launch of StimRouter System
Bioness announced the first series of successful StimRouter Neuromodulation System implantations in Europe at Radboud University Medical Center (Nijmegen, Netherlands), South Victoria University (Cork, Ireland), and Kliniek Park Leopold Chirec (Brussels, Belgium). With the successful launch continuing, Bioness plans to further support clinicians across the continent who are looking to support patients seeking minimally-invasive, long-term pain relief.
The StimRouter received CE Mark approval in February 2014 and received U.S. Food and Drug Administration (FDA) clearance in February 2015.
See more information on the StimRouter on Meddevicetracker.
Teleflex announced 510(k) clearance by the Food and Drug Administration (FDA) and US commercial launch of the TrapLiner Catheter, indicated for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of the guidewire within the vasculature.
The TrapLiner Catheter can be used as an alternative method to the trapping technique that requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position.
See more information on the TrapLine Catheter on Meddevicetracker.
Seventh Sense Biosystems announced U.S. Food and Drug Administration (FDA) clearance for the TAP Blood Collection Device, specifically to test the HbA1c levels in patients with diabetes and prediabetes. The company plans to add more assays for use with the device. The TAP device is a “virtually painless” alternative to traditional blood draws, placed on the upper arm, it fires an array of microneedles into the skin, making tiny punctures. Seventh Sense Biosystems will roll out the device in the coming months.
See more information on the TAP Blood Collection Device on Meddevicetracker.
Boston Scientific said it is recalling its Lotus range of heart devices. The company recently received an increasing number of reports of Lotus Valves that could not be implanted due to the premature release of the pin connecting the valve to the delivery system. When this event occurs, the valve must be re-sheathed and removed from the patient. The elevated trend data caused the company to institute a voluntary field action affecting all Lotus Valve Systems, including Lotus with Depth Guard, and Boston Scientific is removing devices from commercial and clinical sites globally.
The company says it expects to bring the Lotus Valve platform back to Europe by Q4 2017 and it is pushing out Edge timing by 6 months, resulting in a US PMA submission in Q4 2017 and U.S. launch by mid-2018, depending on regulatory review cycle times
See more information on the Lotus Valve on Meddevicetracker.
The Circulatory System Devices Panel of the Food and Drug Administration unanimously agreed that the device appears to safe as used in context of transcatheter aortic valve (TAVR) procedure for use in hands of well-trained individuals. While the panel has some concerns, there are no alternatives, and this is a relatively low-risk device.
See more information on the SENTINEL System on Meddevicetracker.
Accelerate Diagnostics Receives De Novo Approval for Pheno System
Accelerate Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted the de novo request to market the Accelerate Pheno system and Accelerate PhenoTest BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the leading cause of sepsis.
The Accelerate clinical study included more than 39,000 tests conducted on 1,850 samples across 13 trial sites and exceeded the requirements of the FDA for identification and antimicrobial susceptibility testing.
See more information on Accelerate’s Pheno System and PhenoTest BC Kit on Meddevicetracker.
February 24, 2017
Intersect ENT Receives U.S. Approval for PROPEL Contour Implant
Intersect ENT announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its PROPEL Contour steroid releasing sinus implant. PROPEL Contour features an innovative hourglass design that facilitates treatment of patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses.
Positive data from the PROPEL Contour cohort of the PROGRESS Study supported the approval. The study met its primary efficacy endpoint, demonstrating a statistically significant 65 percent relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or the need for oral steroid prescription, compared to surgery alone.
See more information on the PROPEL Contour on Meddevicetracker.