Avenu Medical Receives CE Approval for the Vascular Access System

 

Avenu Medical, Inc. announced today that it has received CE Mark approval for the commercial sale of its Ellipsys® Vascular Access System, an innovative, single catheter image-guided system designed to meet the 21st century needs of vascular access for hemodialysis. With this authorization, Avenu can now launch the technology at clinical centers of excellence throughout Europe.

A groundbreaking innovation for dialysis patients and clinicians, Avenu’s Ellipsys is the first medical device to be approved for study under an Investigational Device Exemption (IDE) by the FDA for minimally invasive creation of arteriovenous (AV) fistulas. The current gold standard of surgical fistula creation was established in 1966 and has not been significantly advanced since its inception 50 years ago.

News of Avenu receiving the CE Mark also comes on the heels of the company reaching full patient enrollment in its FDA-authorized pivotal phase III IDE clinical trial. This multi-center study is designed to demonstrate the safety and efficacy for the percutaneous creation of AV fistulas. The Company intends to file for FDA market authorization later this year.

Dialysis patients require consistent, effective, reproducible, and permanent vascular access. Meanwhile, surgical AV fistulas fail 40-60% of the time, often take several months to achieve usability and require multiple interventions to maintain functionality. In addition, patients often wait five months or longer to get a functioning surgical AV fistula. These factors result in the patients’ extended exposure to central venous catheters, which can lead to increased risks for infection and mortality. Avenu’s Ellipsys System introduces a modern alternative. Thanks to this new technology, clinicians now have a less invasive alternative to the creation of AV fistulas.

More details can be found from Avenu Medical website.

Early detection system for catheter infections

Urinary catheters are used in people who have difficulty passing urine naturally and are often used during or after surgery, for patients with enlarged prostates or in some cases to manage incontinence.

100 million urinary catheters are used annually across the globe, but associated infections can be experienced by up to half of patients using catheters long-term and can lead to kidney failure, septicaemia and death.



The research team led by the University of Bath and including scientists from the University of Brighton, has developed a chemical coating that can be applied to the catheter tip, which releases a coloured dye when the urine becomes alkaline due to a bacterial infection.

The prototype system gives a 12 hour warning of infections before they cause blockages, alerting healthcare professionals before an infection takes hold. This avoids the need for treating patients with antibiotics as a precaution, which can increase the worldwide problem of antibiotic resistance.

Dr Toby Jenkins, from the University of Bath’s Department of Chemistry, led the team. He explained: “Catheter infections are such a common problem that currently anyone using a catheter for more than seven days is given a course of antibiotics to prevent infection.

“The coating we’ve developed will give a 12 hour warning before an infection causes a blockage, meaning that only patients with an infection need to be treated with antibiotics.

“This system could therefore not only save lives but also reduce the threat of antibiotic resistance.”

Experiments by the researchers, using a glass bladder infection model, and published in the journal Biosensors and Bioelectronics, show that the dye is released around 12 hours before catheter blockage by the infective bacteria (Proteus mirablis). The system therefore gives an early warning to change the catheter and treat the infection before it causes serious damage.

Scarlet Milo, Annett Charitable Trust PhD scholar at Bath and first author of the paper, added: “When an infection develops, the bacteria converts a chemical called urea in the urine into ammonia, raising the pH of the urine.



“The coating we’ve developed consists of two layers which can be used with existing catheters: the top layer is a pH sensitive polymer which dissolves if the pH rises above 8, indicating infection.

“This exposes the bottom layer of the coating, which is a gel containing a non-toxic dye which is released into the urine drainage bag, turning it bright yellow.”

The researchers are now looking to work with an industry partner to develop the prototype further.

More information can be found from Bath University website by clicking this link.

Direct Flow Medical Launches Transcatheter Aortic Valve System in Europe

Direct Flow Medical announced European commercial market launch of the DirecTrack™ Delivery System, a next generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.

The Direct Flow Medical transcatheter aortic valve system, with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.

The next generation DirecTrack Delivery System features advanced ergonomic design and functionality to provide physicians with greater procedural control during valve implantation. “I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery” stated Joachim Schofer, M.D., Professor of Cardiology, Hamburg University Cardiovascular Center, Hamburg. He continued, “I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome.”

“We’re pleased to provide physicians with this latest advance in TAVI procedural control” stated Dan Lemaitre, President and CEO, Direct Flow Medical. He said, “The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome.”

A press release can be found from Direct Flow Medical website by clicking here.