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RAQA NEWS ROUND UP - (wc 18.03.19)

Medtech medical devices regulatory FDA RAQA

RAQA NEWS ROUND UP - (wc 18.03.19)

BIOTRONIK Wins FDA Approval for Two High-Voltage Families of Cardiac Implants

BIOTRONIK'S Acticor and Rivacor high voltage cardiac rhythm implants have received FDA approval.

The implants, designed to treat tachycardia are equipped with a new BIOshape and are said to be less irritating on tissues. They also have a longer battery life and up to 15 year lifetime meaning fewer replacement procedures will be required. The devices are 3 Tesla MR-conditional which will allow patients to undergo MRI scans if necessary.

In a published statement Dr. Larry A. Chinitz, a cardiac electrophysiologist in New York City said:

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features”

“We are often forced to choose between important features, which could compromise optimal patient care. The approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size, and greater MRI access (3 Tesla). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk.”


Sonavex EchoSure Vascular Blood Flow Monitor Cleared in U.S.

Baltimore based Sonavex has gained FDA clearance of its vascular blood flow monitor, EchoSure.

The system uses a combination of 3D ultrasound and algorithm learning AI to automate blood flow monitoring, allowing for quick understanding of any complications. By using Sonavex's already cleared EchoMark bioresorbable markers in conjunction with the monitor, specialised sonographers will no longer be necessary during vascular and microvascular surgeries.

Once configured, the system can share its readings on an app viewed by the surgeon, allowing for remote decisions to be made should there be a change in the patient’s condition.

“For decades, the surgical community has sought a simple, fast and non-invasive way to accurately quantify blood flow after microvascular and vascular surgeries,” said Devin O’Brien Coon, MD, Chief Medical Officer and President of Sonavex and a board-certified plastic and microvascular surgeon at Johns Hopkins.

“Putting ultrasound technology in the hands of bedside nurses for the first time may enable detection of vascular compromise earlier than clinical observation alone, providing opportunities for more rapid intervention and improved patient outcomes.”


BD Venovo Stent Approved in U.S. to Treat Iliofemoral Venous Occlusive Disease

Becton Dickinson (BD) has been awarded FDA approval for its Venovo venous stent system designed to treat Iliofemoral Venous Occlusive disease (a narrowing of the iliofemoral vein)

The stent, made from a flexible nitinol material, has been designed to treat blocked iliac and femoral veins and has the combined radial strength, compression resistance and flexibility to treat iliofemoral lesions. 

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” in a published statement said Dr. Michael Dake, University of Arizona and the principal investigator for the Venovo IDE trial.

“Most importantly, it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”

The decision to grant approval was based on data from the VERNACULAR trial that included 170 participants who were treated with the Venovo stent. The study found a weighted primary patency rate of 88.3%, with a 96.9% patency rate in non-thrombotic lesions, and an 81.3% patency rate in post-thrombotic lesions at 12 months.

“The FDA premarket approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an under-recognised condition,” said Steve Williamson, worldwide president of Peripheral Intervention at BD.

“We designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions. Clinicians will now have access to the broadest range of stent sizes in the USA for these difficult-to-treat lesions.”

The Venovo venous stent is available in the USA, Europe, Mexico, Brazil, Argentina, Australia, Egypt, India, Israel, Russia, Saudi Arabia, Singapore and Taiwan.


Nyxoah’s Genio Implant for Obstructive Sleep Apnea Cleared in Europe

Belgium based Nyxoah has been given European regulatory approval for its Genio implant to treat obstructive sleep apnea.

The disorder, caused by the tongue blocking the airway at night, is usually treated by positive airway pressure (PAP) which involves wearing a mask with an air hose connected to it and raising the tongue to allow the air to flow through.

Nyxoah's implant, however, includes a surgically inserted neurostimulator that electrically controls the nerves of the tongue to move it away from the airway. The patient will be required to wear a disposable battery patch under their chin which in turn sends radio frequency signals to the implant, meaning the implant itself does not require a battery, giving the implant a longer lifetime without needing replacement.

In a press release the company stated:

“The Genio® system is the world’s first and only battery-free, leadless and minimally invasive neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation for moderate to severe OSA patients who have failed conventional Positive Airway Pressure (PAP) therapy.

The CE Mark approval was based on data from the Nyxoah BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinical study. The BLAST OSA trial is a prospective study that evaluated the safety and performance of the Genio® system in 7 centres in France and Australia. The BLAST OSA study results will be published in a leading medical journal later in 2019.

The company is now focussing on gaining FDA approval for use in the US.


Mobilett Elara Max X-ray Cleared in the United States

Siemens Healthineers has gained FDA clearance for its Mobilett Elara Max X-Ray system.

The compact and mobile design of the machine allows for better manoeuvrability and features an antibacterial coating. The systems IT security maintains patient confidentiality and is compatible with hospital IT systems thanks to a Window 10-based workstation.

“Siemens Healthineers is pleased to offer the Mobilett Elara Max, a mobile X-ray system with advanced cybersecurity features that provide state-of-the-art patient data protection. The system’s virtual workstation digitalizes healthcare by allowing technologists to access important patient information right at the bedside rather than return to the radiology department,” Siemens Healthineers NA X-ray products VP Scott Watson said in a press release.

The system also features a "long-necked Giraffe" themed version for paediatrics.

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