RAQA NEWS ROUND UP - (wc 19.08.19)

25 August 2019


FDA grants breakthrough status to V-Wave’s interatrial shunt

V-WaveThe FDA has granted breakthrough device designation to V-Wave’s interatrial shunt. It is designed for the treatment of patients with symptomatic heart failure (HF) by utilising this minimally invasive device to relieve increased left atrial pressure (LAP), in turn decreasing fluid build-up in the lungs.
This is to overcome the high number of HF hospitalisations due to lung fluid build-up.

V-Wave CEO Neal Eigler said: “This breakthrough designation provides V-Wave with additional options for FDA communication that will facilitate collaboration, as well as a prioritised review of submissions and marketing applications.

Device to treat advanced heart failure, given go ahead

CRXCVRx’s Barostim Neo System has been given FDA approval.

Implanted below the collarbone, the device has a lead that goes to the cartoid artery in the neck. The device is then programmed to send electrical impulses to the baroreceptor cells in the neck. These identify blood flow patterns through the carotid arteries which allows the brain to send signals to relax the heart.

Over 400 participants took part in the trial, which saw the FDA

European clearance for Nexus

mixonixThe Nexus surgical platform, manufactured by Mixonix, has been given European CE approval.

Marketed as having an easy touchscreen operation, The Nexus combines the capabilities of Mixonix’s three existing products into one system that can be used to perform tumour resections, bone corrections, and a various other procedures.

“Nexus marks an important leap forward for our Company, as we are bringing to market a powerful and highly integrated, easy-to-use system that we are confident will benefit both healthcare providers and patients by incorporating the latest advances in ultrasonic technology for increased efficiency and efficacy. Given the important benefits Nexus brings to both physicians and patients, we are confident that our ability to enter the European market will help deliver improved outcomes for treatments across <a range of areas>” said Stavros Vizirgianakis, President and Chief Executive Officer of Misonix.

Hair loss in chemotherapy patients given boost

cooling capSwedish company Dignitana, secured FDA clearance for its DigniCap Delta scalp cooling system.

Designed to prevent hair loss in patients who are fighting solid tumours via chemotherapy, this is the fourth generation of the system.

Sensors decide what level of cool liquid is pumped into a cap which constricts the blood vessels in the scalp, thus minimising the volume of chemotherapy that can get through to the hair follicles.

Not only is it significantly smaller than the previous model, but it is able to maintain precise temperatures.

To see it in action view here: