May's top stories: UK researches spinal injuries, HeartWare issues device correction
Engineers at the UK's University of Portsmouth are researching new ways to treat patients affected by vertebral fractures while HeartWare issued a voluntary correction notice about earlier-than-expected battery depletion. Medicaldevice-network.com wraps-up the key headlines from May 2014.
Cook Medical reported 12-month follow-up data from the postmarket surveillance (PMS) study in Japan for its Zilver PTX drug-eluting stent.
The 12-month follow-up data from the Japan PMS study showed that patients who received the Zilver PTX drug-eluting stent showed positive results in keeping open the superficial femoral artery.
The PMS study, which included 907 peripheral arterial disease patients, was designed to evaluate the performance of the Zilver PTX drug-eluting stent in real-world patient use. Of the 907 Japanese patients, 838 were eligible for one-year follow up.
Medtronic obtained CE Mark approval for its NC Euphora noncompliant balloon dilatation catheter, which the company states provides improved deliverability and controlled growth for challenging coronary angioplasty procedures.
With CE Mark approval, the NC Euphora balloon catheter is now available in Europe and other countries outside of the US that recognise the status.
Medtronic's NC Euphora balloon dilatation catheter helps ensure implanted drug-eluting stents are fully apposed so that they can properly transfer therapy to the artery wall, reducing the risk for restenosis and stent thrombosis related to under-expansion.
US-based Fisher Wallace Laboratories obtained approval from Health Canada for its Fisher Wallace Stimulator, a portable brain stimulation device designed for treating insomnia and chronic pain.
The battery-powered medical device delivers a gentle electrical current to the brain to stimulate the production of serotonin, melatonin and other neurotransmitters responsible for healthy sleep and pain suppression.
Health Canada has approved the Fisher Wallace Stimulator based on the evaluation of safety and effectiveness data obtained from multiple published studies involving hundreds of patients.
Engineers at the UK's University of Portsmouth are researching new ways to treat patients affected by vertebral fractures.
Aiming to improve surgical outcomes and patient care, the research will evaluate the efficacy of new bioactive materials, which will help form new bone in the treated vertebra over time compared with traditional products currently in use.
As part of the research, engineers are also are trying to understand how the spine treated with the new biomaterials will behave in post-operative scenarios.
Boston Scientific acquired Bayer HealthCare's Interventional device business in a deal worth $415m.
The acquisition is expected to strengthen Boston Scientific's access to a number of segments in the peripheral space, including the atherectomy and thrombectomy categories.
The transaction will include Bayer's AngioJet and Jetstream systems, and the Fetch2 Aspiration Catheter used in cardiology, radiology and peripheral vascular procedures.
Idera Pharmaceuticals entered into an agreement with Abbott to develop an in-vitro companion diagnostic test for use in Idera's clinical development programmes to treat certain genetically defined forms of B-cell lymphoma with its lead drug candidate IMO-8400.
Under the terms of agreement, Abbott will develop a test using polymerase chain reaction (PCR) technology to identify the presence of the MYD88 L265P oncogenic mutation in tumour biopsy samples with high sensitivity and specificity.
According to Idera, this mutation can be identified in approximately 90% of patients with Waldenström's macroglobulinemia and around 30% of patients with the ABC sub-type of diffuse large B-cell lymphoma.
Developer and manufacturer of miniaturised implantable heart pumps or ventricular assist devices (VAD), HeartWare International, issued a voluntary correction notice about earlier-than-expected battery depletion and routine battery handling in the HeartWare ventricular assist system due to a rise in customer complaints.
The HeartWare ventricular assist system is designed as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
The company is providing information to assist patients and clinicians in monitoring battery performance, recognising abnormal behaviours and reinforcing proper power management.
DEKA Integrated Solutions obtained marketing approval from the US Food and Drug Administration (FDA) for its DEKA Arm system, a prosthetic arm that performs multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
The FDA has approved the DEKA Arm system after reviewing data, including US Department of Veterans Affairs' four-site study, with 90% of study participants who used the device able to perform complex tasks.
In the study, 36 participants provided data on how the arm performed in common household and self-care tasks.