Boston Scientific (Natick, Massachusetts) has received CE mark for the Vercise Deep Brain Stimulation (DBS) system for the treatment of tremor, including the most common form of this movement disorder known as essential tremor (ET). Tremor is characterized by involuntary and rhythmic shaking, usually associated with difficulty in an activity such as writing or holding and controlling items.
Experts say ET may be as much as 20 times more prevalent than Parkinson's disease. Boston Scientific says the Vercise DBS system is the first system designed to offer precise neural targeting, allowing physicians to customize therapy for patients with ET. It also features a rechargeable battery that can last up to 25 years.
One of the first commercial implantations of the Vercise DBS System for ET was performed at the University Hospital Cologne, Germany, by a team of physicians, led by Veerle Visser Vandewalle, Head of the Department of Stereotaxy and Functional Neurosurgery, and Lars Timmermann, neurologist and professor of Neurological Movement Disorders.
"Essential tremor can be very debilitating for patients in their day-to-day activities such as writing and eating," said Vandewalle. "The Vercise DBS System provides advanced tremor care through precise neural targeting that is designed to manage ET symptoms effectively and improve patient quality of life."
ET can be a progressive disorder, typically starting on one side of the body, and then gradually affecting both sides. It is most commonly seen in older adults, however the onset of symptoms may occur at any age. The exact cause for ET is unknown, but it is found to be mostly hereditary, where children of a parent who has ET have a 50% chance of inheriting the condition.
The Vercise DBS System has both CE mark and TGA (Australia Therapeutic Goods Administration) approval for the treatment of Parkinson's disease.
Opko launches 4Kscore test in Europe
Opko Health (Miami) reported the European launch of the 4Kscore test, the only blood test that accurately identifies risk for aggressive prostate cancer, through its wholly owned subsidiary, Opko Health Spain. The launch in Europe follows the U.S. launch of the 4Kscore earlier this year.
The 4Kscore is a blood test that provides a patient his individualized risk for aggressive prostate cancer. The panel of biomarkers used in the 4Kscore is based on over a decade of clinical research conducted in Europe by investigators from Memorial Sloan-Kettering Cancer Center and leading European medical institutions involving over 10,000 patients. The 4Kscore Test was developed and validated by Opko Lab in a 1,012 patient blinded, prospective study in the U.S. in 2014. "We are proud to now offer the 4Kscore Test to European clinicians and patients," said Julián Agut Sánchez, CEO of Opko Health Europe.
The European launch of the 4Kscore Test is being done in partnership with Barnaclínic, a branch of Hospital Clínic de Barcelona, a clinical laboratories in Europe.
Opko says the 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2). These biomarkers are combined with a patient's age, Digital Rectal Exam status (nodule/no nodule), and prior negative biopsy status (yes/no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between a Urologist and patient.
Novalis: Three Novalis Centers
in the UK certified in radiosurgery
The Clatterbridge Cancer Center in Aintree Liverpool, The Edinburgh Cancer Center and The Christie at Salford Royal in Manchester are the first centers in Europe to receive a certification of compliance to a new emerging quality standard for radiosurgery, following an independent audit through an internationally recognized expert committee.
The "Novalis Standard" specifies best practice in radiosurgery regarding specific workflows delivered with a premium configuration of components, personnel requirements, commissioning and quality assurance. The Novalis Circle (Cambridge, UK) user community, sharing one of the leading technologies for radiosurgery, established this standard for safe radiosurgery.
The Novalis Circle, a network of clinicians, is dedicated to the advancement of radiosurgery. Novalis Radiosurgery users represent the leading edge in the application of radiosurgery and SBRT and their participation in the Novalis Circle community indicates their strong commitment to improving healthcare. The Novalis Circle provides a communication and collaboration network for developing new ideas and improving treatments that will continue to change the face of cancer treatment.
The Clatterbridge Cancer Center is one of the largest networked cancer centers in the UK, and its radiotherapy treatment center on the Aintree Hospital site in Liverpool is located adjacent to the UK's only specialist neuroscience NHS Trust.
Edinburgh Cancer Center covers a catchment area of 1.4 million people from south east Scotland, treating more than 3,600 patients each year.
The Christie NHS Foundation Trust treats 40,000 patients a year and has been pioneering cancer research for more than 100 years.
The Christie at Salford Royal radiotherapy center, which opened in July 2011, houses two Novalis Texas radiotherapy machines.
Salford Royal NHS Foundation Trust is a provider of hospital, community and primary care services.