Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus.
The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in non-flowing shunts, the Lowell, Mass.-based company said.
“For the first time in over half a century there has been a game changing improvement in the field of hydrocephalus treatment. Ventricular shunting can help save lives and improve the quality of life that otherwise most patients with hydrocephalus would never experience. However, shunt failures can be abrupt, without warning, carry significant morbidity, and be life-threatening. The implantation of Alcyone’s new Alivio Shunt System will enable neurosurgeons with the ability to provide emergency treatment during shunt malfunctions, delivered completely non-invasively, preventing neurological decline and allowing time for patients to reach definitive neurosurgical care,” Dr. Ramin Eskandari of the Medical University of South Carolina said in a prepared release.
Alcyone said the device is intended to offer an alternative to revision surgeries often required to prevent shunt failures in patients with hydrocephalus.
“Patients and families dealing with hydrocephalus deserve a better quality of life and It is our hope that the Alivio System will provide peace-of-mind to these patients, and families, living in fear and worry of potential abrupt shunt occlusions. We are grateful to the patients and families with hydrocephalus, and clinicians treating these patients, for the encouragement and support. We are excited to launch this product in the US and EU early in 2018,” Alcyone founder & CEO PJ Anand said in a press release.
According to the Hydrocephalus Association, at least 50% of patients implanted with shunts suffer shunt failures and blockages within 2 years and require revision surgeries. Approximately 40% of obstructions have also been shown to occur within the 1st year post-surgery.
“We are tremendously excited about the FDA clearance of this new technology focused on potentially reducing the number of emergency surgeries that may be required for members of our community. The Hydrocephalus Association is committed to finding a cure and improving the lives of people living with hydrocephalus through research, advocacy, education and support services,” Hydrocephalus Association prez & CEO Diana Gray said in a prepared statement.
Last August, Alcyone said it was seeking FDA approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in a study at Boston Children’s Hospital.