Rivermark Medical has announced the successful first-in-human (FIH) use of its FloStent System as part of the company’s RAPID-1 FIH clinical study. The procedures were performed on 15 patients by Principal Investigator (PI) and urologist Ingrid Perscky Arravanti (Universidad de Panamá, Panama City, Panama) and proctored by Primary Clinical Advisor and urologist Dean Elterman (University of Toronto, Toronto, Canada) at the Pacifica Salud Hospital and the Panama Clinic in Panama City, Panama. The study evaluates the delivery, safety, and clinical effectiveness of the FloStent System for treating the symptoms of benign prostatic hyperplasia (BPH).
“I am pleased to be a part of the initial cases and remain very impressed by the performance of the FloStent System. I was able to easily position and deploy the implant with standard equipment, using familiar endoscopic techniques,” stated Perscky Arravanti, who is also founder of the Global Men’s Health Foundation. “This therapy is extremely attractive as it offers patients instant improvement in BPH symptoms without the inconvenience and discomfort of traditional treatments.”
The Flostent System is intended to be the preferred first-line device treatment for BPH. The outpatient procedure involves the placement of a nitinol stent during a routine flexible cystoscopy with minimal patient recovery time and no need for a urethral catheter. The stent gently holds the prostatic urethra open to restore normal urinary function, preserve sexual function, and improve a patient’s overall quality of life. If desired, the device can be easily retrieved or repositioned after implantation.
“Watching the FloStent procedures first-hand, I am enthusiastic about the ease of use and immediacy of BPH symptom relief,” said Dean Elterman, faculty member at the University of Toronto’s Division of Urology. “Being able to perform this procedure quickly using common flexible cystoscopes will allow urologists worldwide to offer the FloStent System in a variety of outpatient settings, making it easier for patients to seek and receive device treatment.”
“Today marks an important milestone as Rivermark transitions into a clinical-stage company,” commented Adam Kadlec, CEO of Rivermark Medical and practising urologist at Advocate Health in Milwaukee, USA. “We are excited at the prospect of being able to offer the most accessible BPH device therapy in the world—a first-line, minimally Invasive outpatient therapy that can be performed with existing equipment, offering BPH patients immediate and reliable relief. In the coming months, we look forward to building upon the momentum of our FIH experience by gathering additional clinical evidence demonstrating the value of the FloStent System.”