Medical device firm Embolx has secured CE mark approval for its next-generation Sniper balloon occlusion microcatheters for pressure-directed treatment of cancerous tumors, enlarged prostate and uterine fibroids.
Available both in the US and Europe, the microcatheters feature a system to deliver pressure-directed arterial embolization therapy.
Sniper microcatheters will enhance the therapeutic agent delivery to target areas, while protecting surrounding healthy tissues, through controlling pressure to alter blood flow.
The company is providing new microcatheters in 110cm, 130cm and 150cm lengths to help interventional radiologist physicians access via femoral or radial arterial sites.
Sniper balloon and atraumatic tip designs have been advanced to occlude larger vessels and enhance the ability for Sniper to track inside vessels.
Embolx president and CEO Michael Allen said: “CE Marking is an important milestone for Embolx, as we can now offer the most advanced transarterial embolization delivery system to physicians and patients in Europe.
“For patients, the system’s ability to redirect blood flow away from surrounding organs and eliminate reflux may result in better outcomes and fewer side effects.”
Recently, the United Kingdom’s National Institute for Health and Care Excellence (NICE) has announced the support to prostate artery embolization (PAE) to treat patients with benign prostatic hyperplasia.
Sniper is said to become the device of choice for PAE procedures, as it holds capacity to avoid reflux and redirect blood flow away from surrounding organs.
Portugal’s Hospital Saint Louis interventional radiologist Dr Tiago Bilhim said: “We’ve used Sniper in approximately 50 prostate arterial embolizations so far this year, and we’ve seen improved outcomes with fewer adverse events when compared to conventional microcatheter embolization.
In June this year, the company secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next generation Sniper balloon occlusion microcatheter for pressure-directed arterial embolization therapy.
Based in Silicon Valley, Embolx is a commercial-stage medical device firm engaged in the development of microcatheters for arterial embolization procedures.
The company’s solutions will help enhance treatment for different conditions, including cancerous tumors, benign prostatic hyperplasia and uterine fibroids.