Acclarent Launches Balloon Sinuplasty System for Children

Acclarent Inc. has launched the Relieva Spin Balloon Sinuplasty System with the M-110C Sinus Guide Catheter Tip designed to access small and tight sinus anatomy in children and adults. The product — now available in the United States — represents a new addition to Acclarent’s Balloon Sinuplasty portfolio, which physicians use to treat children who suffer from chronic maxillary sinusitis.

Balloon Sinuplasty Technology is a safe and minimally invasive system that widens the sinus openings of patients suffering from chronic sinusitis.

Sinusitis is one of the most common chronic health problems in the U.S., with 18 million office visits per year for chronic sinusitis, according to industry estimates. Patients with chronic rhinosinusitis typically suffer from a combination of headaches, congestion, facial pain/pressure, and other symptoms impacting their physical, functional, and emotional quality of life. While chronic sinusitis is typically treated first with medication, at least 20 percent of patients do not respond adequately to such treatment.For children suffering from this condition, it can result in considerable loss of school time and accumulation of medical expenses, experts said.

“Acclarent is pleased to offer the Relieva Spin Balloon Sinuplasty System for children who suffer from chronic maxillary sinusitis,” said Howard Levine, M.D., an otolaryngologist and Acclarent vice president of Clinical and Medical Affairs. “Our balloon technology has been used in over 300,000 adults and children who suffer from chronic sinusitis and this launch continues to support Acclarent’s mission to provide sinus relief to children as well.”

The Relieva Spin Balloon Sinuplasty System provides a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, Relieva Spin Balloon Sinuplasty System is designed to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. The new Relieva Spin M-110C sinus guide catheter tip is designed to work with the existing Relieva Spin Balloon Sinuplasty System portfolio, and to access small and tight anatomy.

“The Relieva Spin Balloon Sinuplasty System is a single-handed system to access and dilate sinus cavities and offers flexible over-the-wire technology,” said Eric Waki, M.D., a pediatric otolaryngologist. “The product’s design allows me to effectively treat all different types of patients, including adults and children with small anatomy.”

Acclarent Inc., a business unit of Johnson & Johnson, is located in Menlo Park, CA. The company designs, develops and commercializes medical devices that address ear, nose and throat conditions.