Boston Scientific has received CE Mark for the LOTUS Edge™ Valve System, the company’s next generation transcatheter aortic valve implantation (TAVI) technology. The LOTUS Edge valve system is indicated for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.
In comparison to the Lotus™ Valve System, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. Another differentiating feature of the LOTUS Edge valve system is the inclusion of Depth Guard™, a design element intended to reduce the need for a permanent pacemaker (PPM).
A press release is available from Boston Scientific website.
Dr. Amy Paller, who has spent 30 years researching the disorder, for the first time has found the reason the disease causes the red skin and has a promising biologic drug to begin testing soon in clinical trials.
In a new study published in the Journal of Allergy and Clinical Immunology, Paller, the Northwestern Medicine chair of dermatology, together with Dr. Emma Guttman-Yassky of Mount Sinai Medical School, discovered that an arm of the immune system – the Th17 pathway – in these patients is way too active, and the higher its activity, the worse the disease severity.
Paller is about to launch a clinical trial to test a new biologic (a cutting-edge drug) for it, with the goal of targeting and calming down this pathway.
More information is available on Northwestern University website.
On September 11-13, 2016, the 7th China International Medical Device Regulatory Forum was held in Chengdu, China. Jiao Hong, Vice Minister of China Food and Drug Administration (CFDA) attended and addressed the opening ceremony of the forum.
With the theme of “standardizing medical device clinical trials, guaranteeing the authenticity of clinical data,” the forum invited domestic and foreign experts to give keynote speeches, and set up more than ten sub-forums on regulatory and industry hot topics, including forums on medical device innovation and post-market surveillance. Directors from CFDA’s medical device regulatory departments and technical institutions interpreted related policies, laws, regulations and technical requirements of China. Experts from domestic and foreign medical device regulatory and technical departments and medical device industry exchanged latest information on medical device related regulations, new products and new technologies.
Researcher Christopher Stroupe at School of Medicine, University of Virginia, has his eye on six little molecules that could be the key to new treatments for both Ebola and cancer. The molecules, which act together as a single unit known as HOPS, are essential for Ebola to infect cells and for cancer cells to grow and survive. As such, they represent a shared weakness – a weakness Stroupe is seeking to exploit. To do that, he is creating a new tool to produce a purified form of HOPS that would facilitate the development of drugs targeting the molecules. By blocking HOPS in human cells, he hopes, doctors can cut the legs from under Ebola and cancer.
Full story can be found from University of Virginia website.
BD announced the launch of its next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep, with new traceability and secure patient health record documentation features and functionality.
The new wireless BD Veritor™ Plus System provides health care providers and laboratorians in physician offices, clinics, hospitals and integrated delivery networks (IDNs) with objective, lab-quality immunoassay test results within minutes. This rapid and accurate solution streamlines the point-of-care (POC) diagnostic workflow and enables providers to quickly review patient results to assist in determining the appropriate treatment in a single consultation. The system can help detect influenza A and B, respiratory syncytial virus (RSV) and group A strep while the patient is still on site, which enables faster decision making for an earlier intervention opportunity.
A press release can be found from BD website.