AZORRA LLC Revolutionizes Staghorn Calculus Management with Innovative New Device

Fort Lauderdale, FL – November 8, 2023 – AZORRA LLC, a medical device company based in Fort Lauderdale, Florida, today announced the launch of a groundbreaking new device designed to significantly improve the management of staghorn calculi – those notoriously complex and challenging kidney stones. This device, currently undergoing final regulatory approvals, promises a less invasive, more effective approach to breaking down and removing these large, branched stones, potentially saving patients from painful surgeries and prolonged recovery times. “We’re really excited about this,” says a representative from AZORRA LLC. “For years, dealing with staghorn calculi has been a huge headache for both patients and doctors. Traditional methods often mean lengthy hospital stays and procedures that can be pretty rough on the body. We felt there had to be a better way.” The Problem with Staghorn Calculi Staghorn calculi get their name because they resemble the antlers of a stag (male deer). They form when calcium, uric acid, or struvite accumulate in the kidneys, branching out to fill the entire collecting system. Unlike smaller kidney stones that may pass on their own, staghorn stones are far too large and complex. “Think of it like a tangled, branched tree root system inside your kidney,” explains Dr. Eleanor Vance, a urologist who’s been involved in preliminary testing of the AZORRA device. “Getting those branches broken down and removed without causing damage to the kidney is the big challenge.” Currently, treatment options generally fall into a few categories: Percutaneous Nephrolithotomy (PCNL): This involves surgically creating a tunnel through the skin into the kidney to directly access and remove the stone. It’s effective, but also invasive, requiring general anesthesia and a significant recovery period. Shock Wave Lithotripsy (SWL): Uses shock waves to break the stone into smaller pieces that can hopefully pass. It’s less invasive, but often isn't effective for large, dense staghorn stones and may require multiple treatments. Ureteroscopy: A small scope is passed through the urethra and bladder into the kidney to fragment the stone with a laser. This is useful for certain types of stones but can be difficult to navigate the complex branching of a staghorn calculus. “All these methods have their pros and cons,” says the AZORRA representative. “We saw a need for something that combined the effectiveness of PCNL with a less invasive approach.” AZORRA’s Solution: Precision Fragmentation & Efficient Extraction AZORRA LLC’s new device, details of which are still largely proprietary, focuses on two key areas: precise fragmentation and efficient extraction. It's designed to be used in conjunction with standard endoscopic equipment, meaning urologists can integrate it into their existing workflows. "What's really neat about this device is its ability to navigate the complex anatomy of the kidney and deliver focused energy directly to the stone," explains Dr. Vance. “We’re talking about pinpoint accuracy, minimizing damage to surrounding tissue. It’s like having a microscopic jackhammer for kidney stones!” Here’s a breakdown of how it works, as understood from briefings with the company and participating physicians: Advanced Imaging Integration: The device integrates with standard fluoroscopic and endoscopic imaging, providing real-time visualization of the stone and surrounding anatomy. Targeted Energy Delivery: A flexible, articulating tip allows the surgeon to precisely position the energy source – which uses a proprietary combination of ultrasonic and laser technology – directly on the stone. Multi-Modal Fragmentation: The device is capable of both bulk fragmentation (breaking off larger pieces) and micro-fragmentation (reducing the stone to dust-like particles). This allows for a customized approach based on the stone’s composition and location. Integrated Aspiration System: The device features a built-in aspiration system to immediately remove the fragmented stone particles, maintaining a clear field of vision and preventing re-accumulation. Reduced Procedure Times: Preliminary data suggests the device can significantly reduce procedure times compared to traditional PCNL, leading to shorter hospital stays and faster recovery for patients. Early Results & Future Outlook While the device is still awaiting final FDA clearance, early results from clinical studies have been promising. Researchers report: Higher Stone-Free Rates: Patients treated with the AZORRA device have shown significantly higher stone-free rates compared to historical controls treated with traditional methods. Reduced Complications: There appears to be a lower incidence of complications, such as bleeding and infection. Shorter Hospital Stays: Patients are being discharged from the hospital an average of one to two days earlier. Improved Patient Satisfaction: Patients report less pain and a faster recovery. “We’re not claiming this is a magic bullet,” clarifies the AZORRA representative. “Staghorn calculi are still a complex problem. But we believe this device represents a significant step forward in how we treat these stones.” AZORRA LLC is currently working with leading urology centers across the United States to expand clinical trials and gather more data. The company anticipates receiving FDA clearance in the coming months and plans to launch the device commercially in early 2024. “We’re really passionate about improving the lives of patients with kidney stones,” says the AZORRA representative. “We believe this device has the potential to make a real difference.” About AZORRA LLC: AZORRA LLC, headquartered at 201 E Las Olas Blvd Ste 2250, Ft Lauderdale, FL, 33301-4449, United States, is a medical device company dedicated to developing innovative solutions for the treatment of urological disorders. With a focus on precision and minimally invasive techniques, AZORRA is committed to improving patient outcomes and enhancing the quality of life for individuals suffering from kidney stones and other urological conditions. You can reach them at 318-468-6734.