Biocept Inc., of San Diego, reported the publication of a case report demonstrating the clinical utility of its Target Selector ALK gene rearrangement test. The circulating tumor cell based assay detected the ALK gene translocation in a patient diagnosed with non-small-cell lung cancer who subsequently received sequential ALK inhibitor therapies and exhibited excellent clinical response to treatment. The article, "Detecting an ALK Rearrangement via Liquid Biopsy Enabled a Targeted Therapy-Based Approach for Treating a Patient with Advanced NSCLC," was published in the Spring 2018 issue of the journal Oncology & Hematology Review.
Electromed Inc., of New Prague, Minn., reported the results of a longitudinal outcome-based study published in Respiratory Therapy: The Journal of Pulmonary Technique. The longitudinal study shows that high frequency chest wall oscillation (HFCWO) therapy with the Smartvest airway clearance system significantly reduces bronchiectasis-related exacerbations including the need for antibiotics, emergency department visits and hospitalizations, and that this effectiveness was maintained for 2.5 years after the initiation of treatment. The study also found that 68 percent of the patients reported a significant increase in their quality of life. The Smartvest system uses HFCWO to rapidly compresses and releases the chest wall, resulting in an oscillation in airflow within the airways that acts to loosen, thin, and propel mucus toward the major airways where it can be expectorated.
Establishment Labs SA, of Alajuela, Costa Rica, reported the enrollment and successful completion of implant surgery on the first patient in its U.S. IDE clinical trial of its Motiva silicone breast implants. The Motiva implants IDE clinical trial is a single-arm, multicenter trial, designed to measure the safety and effectiveness of the Motiva Smoothsilk and Ergonomix implants in female patients who are undergoing primary breast augmentation, primary breast reconstruction or revision surgery. With a population size of approximately 750 patients over 22 years of age, at up to 40 study sites in the U.S., Canada, Sweden and Germany, the primary safety endpoint is based on the incidence, severity, method of resolution, and duration of all complications on a per-implant and per-subject basis. The use of 3D imaging systems, performed pre-operatively and at 1-10 year visits, will supplement the data and corroborate the manual measurements performed. An MRI sub-study will be done in parallel to determine the percentage of ruptures, with a subset of the treated population selected to obtain MRIs at one, two, four, six, eight and 10 years.
Hesperos Inc., of Orlando, Fla., said it has increased its pioneering human-on-a-chip drug testing capabilities by adding a new in vitro, human-human neuromuscular model to its patented multi-organ microfluidic device systems. The new technology is described in a recent Biomaterials paper titled "Stem cell derived phenotypic human neuromuscular junction model for dose response evaluation of therapeutics." The technology is now licensed to Hesperos and is available as a fee-for-service assay. Unlike other tests that examine neuromuscular function in co-cultures or using biomarker activity and protein analysis, the new model is a functioning platform that recreates human neuronal connections to skeletal muscle. The compartmentalized, serum-free microfluidic device is made with thin silicone membrane with tiny tunnels. Drugs can be applied to the model – in single doses or in several doses over an extended period of time, mimicking real drug evaluation conditions – to measure how the muscle system reacts. In the paper, researchers describe dose response curves generated curare toxin, alpha bungarotoxin and botulinum toxin (Botox). The results closely matched in vivo data at all four stimulation frequencies tested, suggesting the model provides an accurate replica of live human systems. The technology could help inform the design of future clinical trials, and accelerate drug development timelines.
Medtronic plc, of Dublin, reported two-year outcomes for the Harmony transcatheter pulmonary valve (TPV) from its early feasibility study. Presented at the Society for Cardiovascular Angiography and Interventions 41st Annual Scientific Sessions, data from 18 patients revealed the Harmony TPV showed solid valve function and no paravalvular leak. Designed to offer a treatment alternative for patients with congenital heart disease (CHD), the Harmony TPV is being studied in CHD patients born with right ventricular outflow tract (RVOT) anomalies who undergo a surgical repair early in life. For these patients, who account for approximately 80 percent of CHD patients born with RVOT anomalies, the Harmony TPV provides a less invasive option to help restore normal valve function later in life. Patients enrolled in the Harmony TPV early feasibility study who have now been followed out to two years continued to experience strong hemodynamics, with 86.7 percent of patients having no/trace pulmonary regurgitation at two years. Two patients experienced tissue growth within the stent frame and were treated successfully with a transcatheter valve-in-valve procedure with the Melody TPV. The Harmony Pivotal IDE Study is treating up to 40 patients at approximately 15 sites in the U.S., Canada and Japan.
Mobius Imaging LLC, of Shirley, Mass., received 510(k) clearance for its Airo Mobile CT imaging system for pediatric applications. The system previously received 510(k) clearance in 2013 for non-pediatric imaging Primarily used for intraoperative, image guided procedures in neuro-spine surgery, Airo diagnostic images are also used for supporting applications in brachytherapy, radiation therapy and surgical imaging. Pediatric patients can now receive the clinical benefits of Airo CT imaging for diagnostic and intraoperative procedures.