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ICHOR REPERFUSION SYSTEM RECEIVES FDA CLEARANCE.

Euphrates Vascular has received 510(k) clearance for sale of its ICHOR Percutaneous Reperfusion System, which is a minimally-invasive platform designed to treat organized thrombus and embolic events in the peripheral vasculature. Euphrates Vascular is focused on the treatment of vascular occlusions.

Euphrates Vascular has received 510(k) clearance for sale of its ICHOR Percutaneous Reperfusion System. ICHOR is a Percutaneous Reperfusion System designed to treat organized thrombus and embolic events in the peripheral vasculature. ICHOR is a "one size fits all" system that replicates the standard of care of surgical embolectomy / thrombectomy but in a minimally invasive manner:

percutaneous approach reduces surgical complications

mechanism of action minimizes blood loss associated with aspiration

mechanism of action does not require drug therapy which potentiates a reduction of common bleeding complications associated with lytics

does not require general anesthesia

does not require the need for capital equipment (disposable only)

easily adoptable by interventionalists

incorporates a health economic element intended to make ICHOR a first line therapy for physicians, hospitals and office-based labs.

ICHOR Percutaneous Reperfusion System designed to target vascular occlusions by eliminating the need for surgery or drug therapies

ICHOR will be the first marketable product for Euphrates Vascular with the Pulse NanoMED technology in the pipeline. The ICHOR and Pulse NanoMED systems were both designed to target vascular occlusions by eliminating the need for surgery or drug therapies and both attempt to treat further and deeper by overcoming today's size limitations in material science.

"ICHOR will be an extraordinary tool in the clot management toolbox due to its ability to handle the organized clot many physicians struggle to treat. The Pulse NanoMED system may allow for us to change our approach in treating occlusions in areas such as the lower limb, the diabetic foot and perhaps in the neurovasculature, by simply being able to access the most tortuous anatomy and the smallest vasculature. The Pulse NanoMED system can enable us to go where no other devices have gone before," said Dr Troy Long, vascular interventional radiologist.

About Euphrates Vascular

Euphrates Vascular is a medical device company comprised of Pulse Therapeutics and ICHOR Vascular Inc. The Euphrates Vascular vision is to become a leader in the treatment of vascular occlusions with an initial focus in the $3.5B Limb Ischemia market. The technologies will platform beyond peripheral vascular occlusions into Ischemic Stroke, Coronary, Wound Care, Dialysis, Interventional Oncology, and Orthopedic applications.

For more information, visit www.euphratesvascular.com.

AXONICS GRANTED EXPANDED CE MARK LABEL

Axonics Modulation Technologies, Inc. has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (MRI) conditional labeling for the Axonics r-SNM System.

The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1.

Raymond W. Cohen, Chief Executive Officer of Axonics, said, Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S.

Full-body MRI labeling is a significant addition to the many differentiating attributes already offered by the Axonics r-SNM product: a miniaturized and long-lived implantable neurostimulator that is one-third the size of the only competitor and is qualified to last at least 15 years in the body. The Axonics r-SNM System also features, among other things, a fast and safe charging capability with an infrequent charging interval, and a patient- friendly wireless remote control.

This is a game changer, said Karen L. Noblett, M.D., Chief Medical Officer of Axonics. Full-body MRI labeling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labeling eliminates a major concern for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel dysfunction without compromising their quality of life.

What is MRI Conditional Labeling?

MRI is short for Magnetic Resonance Imaging. MR scanners come in different magnet field strengths measured in Tesla or T, usually between 0.5T and 3.0T. They also come in varying sizes including open and wide-bore. Simplistically, an MR scanner is a very large, strong magnet into which a patient lies. A radio wave is used to send signals to the body of the patient. The returning signals are received and converted into images by a computer attached to the MR scanner. The image quality of an MRI depends on signal and field strength. MRI Conditional Labeling means a product has been tested and demonstrated to pose no known hazards to the patient in a specified MRI environment with specified conditions of use and the results of testing are sufficient to characterize the behavior of the product in the MRI environment. Testing for devices that may be placed in the MRI environment should address magnetically induced displacement force and torque, unintended stimulation, and thermal injury. Other possible safety issues include but are not limited to, image artifact, device vibration, interaction among devices, the safe functioning of the device and the safe operation of the MRI system. Any parameter that affects the safety of the device should be listed and any condition that is known to produce an unsafe consequence must be described.

About Overactive Bladder and Sacral Neuromodulation

Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established in the United States and is a covered service in Europe, Canada and Australia.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction. The Axonics r- SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia. The r-SNM System offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived stimulator that is qualified to function for at least 15 years. Also included is a tined lead, as well as patient- friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming.

For more information, visit www.axonicsmodulation.com or call 949/396-6320.
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Publication:Biotech Equipment Update
Date:Mar 1, 2019
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