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The U.S. Food and Drug Administration (FDA) has granted Reach Neuro’s Avantis platform a breakthrough device designation. The prioritisation will be important in an area lacking long-term treatment for stroke patients managing upper body paralysis.

Avantis uses small electrical impulses delivered to the spinal cord to help restore shoulder, arm, and hand movements. The designation by the FDA addresses an absence of a standard of care for patients with long-term paralysis. According to the Pittsburgh, US-based company, the device can directly restore a patient’s ability to control movement and help alongside physical therapy.

The technology is currently being tested in a National Institutes of Health (NIH) funded clinical trial. Previous data, published in the Nature Medicine journal, demonstrated improvements in grip and joint strength. Improvements in functional tasks, like lifting objects and using cutlery, were also seen although long-term effects will likely require chronic implantation of the device.

Moximed has received marketing authorisation from the US Food and Drug Administration (FDA) for its MISHA Knee System.  

MISHA is an implantable shock absorber (ISA) intended for the treatment of people with medial knee OA. This is a common and debilitating condition that affects more than 32 million people in the US.

Moximed founder and CEO Anton Clifford said: “This is a milestone event for knee OA sufferers and it’s the result of unwavering clinical research and development that spans more than ten years. 

“We offer special thanks to our study patients and surgeon investigators who helped advance the understanding of this new treatment for OA. 

“Also, we recognise the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology.” 

The MISHA system is indicated for people who continue to experience pain despite undergoing non-surgical or surgical treatment.

Avation Medical has secured a 510(k) clearance from the US Food and Drug Administration (FDA) for its smart bladder control system, Vivally. 

The non-invasive, bladder-control therapy device and mobile application is intended for the treatment of patients with urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome. The Vivally system helps avoid surgery, drugs or needle electrodes. It is also claimed to be the only approved closed-loop and non-invasive neuromodulation system for bladder control in the US.

The closed-loop control uses the patient’s own physiologic response to objectively confirm activation of the tibial nerve. After activation, it also adjusts therapy parameters to ensure comfort and optimal therapeutic output. 

Avation CEO Jill Schiaparelli said: “Millions of people suffer from urinary urgency and urge urinary incontinence who do not want invasive surgery or the unwanted side-effects of drugs. 

“With 30-minute at-home therapy sessions as little as once per week, and a mobile application with an electronic bladder diary and progress tracking, Vivally provides an effective treatment option that patients can easily fit into their schedule.”

Medical technology company Smith+Nephew has reached an exclusive agreement with Navbit for the distribution of the latter’s disposable navigation device in Japan.

Under the deal, Smith+Nephew will exclusively supply the Navbit Sprint disposable navigation device for use in Japan. The device is a small, disposable, compact navigation tool that can be used for either supine or lateral approaches to primary hip arthroplasty. 

Navbit CEO Lynette Walter said: “Japanese surgeons are the most sophisticated in their field. They are the leaders in understanding the complexities of hip surgery in three dimensions and the impact of movements of the spine and pelvis on the outcomes of hip replacement.” 

Post-operative dislocation is claimed to be the second most common reason for the revision of a total hip replacement globally.

Studies have demonstrated that navigation can reduce the risk of dislocation.

OpSens, a Canada-based medical device cardiology-focused company, has completed enrolment of participants for the SAFE‑TAVI clinical study in Europe.

The SAFE-TAVI study, which has enrolled 120 patients, is designed to evaluate left ventricular rapid-pacing utilising OpSens’ SavvyWire in transcatheter aortic valve implantation procedures (TAVI or TAVR).  

The participants enrolled were those with severe aortic valve stenosis and other conditions that needed a TAVI procedure in which left ventricular rapid pacing was deemed as required. 

The study was undertaken in nine hospitals including eight centres across Spain and one in Canada, at Quebec Heart and Lung Institute – Laval University (IUCPQ). Serving as the global principal investigator of the study, Dr Josep Rodés-Cabau from IUCPQ oversaw and coordinated with the principal investigators from the hospitals in Spain. SavvyWire is leveraged for left ventricular pacing to analyse the potential benefits of removing the requirement for venous access, lowering procedure time and eliminating any potential complications related to right ventricular pacing.