Novel Venous Device for the Treatment of Chronic Pelvic Pain

PROJECT SUMMARY Chronic Pelvic Pain (CPP) is a debilitating condition that impacts 20 percent of women in the United States. Unfortunately, CPP is a challenge to diagnose and treat as there are multiple disease etiologies. Due to its complexity, it often requires a multidisciplinary approach involving gynecologists, urologists, vascular surgeons, and interventional radiologists. CPP is strongly associated with significant impairments in quality of life and has negative impacts on mental health. It is one of the most common conditions treated in women’s health and represents a substantial economic burden on women and health care systems. In fact, an excess of $39 billion USD is spent in direct and indirect costs for CPP in the United States alone each year. Unfortunately, many patients with CPP end up in emergency rooms, or in primary care clinics where they are prescribed opioids for treatment. In 2019, 22.1% of U.S. adults with chronic pain used a prescription opioid. Up to 58% of patients with CPP resort to analgesics including opioids. Research shows that opioid treatment is ineffective for chronic pain syndromes. As opioids are not recommended for CPP, physicians need more options to successfully treat this debilitating condition.Fortunately, V-Flow Medical is providing CPP sufferers with an innovative solution to help diagnose and treat CPP. Up to 40% of CPP cases are caused by pelvic venous insufficiency (PVI), also known as pelvic congestion syndrome (PCS). PVI occurs when there is retrograde blood flow in the ovarian or internal iliac veins. This causes blood stasis, leading to localized venous hypoxia, which in turn activates localized inflammation and activation of pain nociceptors. V-Flow Medical has designed the first diagnostic catheter and modular stent system that has been specifically designed to treat PVI that is caused by pelvic vein compressions (PVCs). In addition to providing excellent visualization of incompetent pelvic veins, a key advantage of the V-Flow V-Gauge catheter is its ability to determine a clinically significant pressure gradient across the compressed zone and pre-determine the clinical benefit of placing a stent through real-time pressure monitoring. This project utilizes an ovine model to evaluate the safety and efficacy of the catheter and stent-in-stent system to generate a successful device that will improve clinical outcomes for millions of women suffering from CPP each year.