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7-year-old Boy Managing His Hydrocephalus with ReFlow™ Ventricular System “Gen 1” Featured on Charleston’s ABC News 4

July 28, 2023

After struggling to conceive a child for what felt like ages, Miranda of Moncks County, South Carolina finally fell pregnant – a miracle that quickly turned into horror when she delivered at 24 weeks in late 2015. At just 1 pound and 12 ounces, her son, Sutton, arrived with life-threatening health issues, including hydrocephalus – a neurological disorder caused by an abnormal buildup of cerebrospinal fluid in the brain that affects more than one million Americans.

During Sutton’s 141-day stay in the NICU, he underwent numerous surgeries. When he was finally discharged, he left with a shunt implanted in his brain to help drain the fluid buildup caused by the hydrocephalus. However, the first few years of Sutton’s life became a blur of emergency hospitalizations and brain surgeries every time his shunt became blocked. Miranda was forced to relive the trauma from her son’s premature birth every time she saw him in another hospital bed. She also constantly worried about the next time her son would require major surgery at a moment’s notice.

In early 2020 Sutton’s neurosurgeon, Dr. Ramin Eskandari of the Medical University of South Carolina, recommended the ReFlow™ Ventricular System – at that time, a newly FDA-cleared medical device that allows hydrocephalus patients and/or their caregivers to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow with the press of a button. Thanks to ReFlow™, Sutton hasn’t been hospitalized or needed surgery in over three years.

Now, Sutton is experiencing life as any 7-year-old would. With his hydrocephalus being managed and his ReFlow™ in place, Sutton’s parents feel a sense of control. For Miranda, that means knowing that there is a routine that requires 30 seconds to flush Sutton’s device, allowing their family to focus on the other important aspects of life like school, faith, and fun. Looking ahead, she hopes that her family’s journey helps others who may be struggling to manage a child’s hydrocephalus, and encourages them to ask their doctor about ReFlow™.

Miranda, Sutton, and Dr. Eskandari recently spoke to ABC News 4 to discuss their experiences with ReFlow™. You can watch the full segment here.

 

The ReFlow™ System Mini and ReFlow™ Mini Flusher are FDA cleared for the following indication:

 

The ReFlow System Mini and the ReFlow Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter’s relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction, and instruction of the treating physician, the ReFlow Mini Flusher may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.

Anuncia Medical Inc. plans to work closely with the medical community and the FDA to conduct larger scale studies to further evaluate use of the ReFlow device to maintain flow.

https://anunciamedical.com/wp-content/uploads/2023/07/7-year-old-Boy-Managing-His-Hydrocephalus-with-ReFlow™-Ventricular-System-Gen-1-Featured-on-Charlestons-ABC-News-4.png 281 500 admin https://anunciamedical.com/wp-content/uploads/2023/12/LowResPNG__Anuncia-Stacked_COLOR_.png admin2023-07-28 16:18:412024-03-18 11:45:267-year-old Boy Managing His Hydrocephalus with ReFlow™ Ventricular System “Gen 1” Featured on Charleston’s ABC News 4

Anuncia Medical Successfully Launches Second Generation Device to Treat Hydrocephalus at Several Leading Neurosurgical Centers Across the United States

July 27, 2023

The ReFlow™ Mini Flusher will Benefit the Lives of Patients in the US and Abroad where Access to Ongoing Advanced Clinical Care can be Limited

SCOTTSDALE, Ariz., July 26, 2023 /PRNewswire/ — Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce the successful U.S. commercial launch of the ReFlow™ Mini Flusher device. Neurosurgeons in the US and soon internationally will now have a new option to reduce the impact of hydrocephalus by providing better access to potentially life-saving therapy for the 30 million patients worldwide suffering from this neurological disorder. Hydrocephalus is a chronic neurological condition in which excess CSF accumulates in the brain, often causing severe symptoms, frequent hospitalizations, and ongoing health concerns, and may be fatal if left untreated.

Data recently published in the Journal of Pediatric Neurosurgery on the first generation ReFlow device suggests that ReFlow prophylactic use, designated as a US FDA Breakthrough Device indication Anuncia intends to further explore in future clinical studies, may reduce the high rate of shunt malfunctions due to catheter occlusions and associated repeat revision brain surgeries. The just launched second-generation ReFlow Mini Flusher is FDA-cleared for use in patients living with hydrocephalus or similar conditions. Its reduced size and profile  are designed to better support a broader hydrocephalus patient population, from infants to older adults. Used in line with any shunt system brand, the patented ReFlow Mini Flusher is uniquely designed to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow with just a simple push of the flusher’s soft dome located beneath the patient’s scalp. Noninvasive flushing with the ReFlow Mini Flusher does not interfere with shunt flow regulation and can be performed in-clinic by trained clinical staff, or anywhere by a trained patient/caregiver, as directed by the treating neurosurgeon.

Since the ReFlow Mini became available earlier this month, multiple leading centers across the country have successfully implanted the technology. Patients are already using the ReFlow Mini to manage their chronic hydrocephalus. Beyond the U.S., Anuncia actively seeks opportunities to assist neurosurgeons in regions where treating the condition remains challenging. Most notably, international news organizations are currently covering a public health crisis in Uganda, highlighting how a bacterial outbreak has led to a new surge in hydrocephalus cases. The Company is currently seeking strategic partners who share the belief that the ReFlow Mini could improve the lives of undermanaged patients.

Read More…

https://anunciamedical.com/wp-content/uploads/2023/08/Blog-Post-Logo.png 430 760 admin https://anunciamedical.com/wp-content/uploads/2023/12/LowResPNG__Anuncia-Stacked_COLOR_.png admin2023-07-27 13:04:452023-12-12 14:22:37Anuncia Medical Successfully Launches Second Generation Device to Treat Hydrocephalus at Several Leading Neurosurgical Centers Across the United States

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Contact your physician to discuss if the ReFlow™ System Mini may be right for you.

Additional information about the ReFlow™ System Mini is available by contacting Anuncia.

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Disclaimer

The ReFlow™ System Mini and ReFlow Mini Flusher are FDA cleared for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The ReFlow™ System Mini and ReFlow™ Mini Flusher are not for everyone; please consult your doctor. The ReFlow™ System Mini and ReFlow™ Mini Flusher are only available in the United States. The ReFlow™ System Mini and ReFlow™ Mini Flusher are prescription devices sold by or on the order of a physician.

Caution: FDA (USA) law restricts this device to sale by or on the order of a physician. Refer to product package insert for instructions, warnings, precautions and complications.

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