Chronic sinusitis implant approved by FDA

FDA approval has been issued to Intersect ENT’s implant offering controlled drug delivery for patients with chronic sinusitis.

The system prevents obstruction of the ethmoid sinus following surgery, reducing the need for additional surgical procedures and systemic steroids that can have serious side effects.

David W. Kennedy, Professor of Otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, USA, said that the combination of minimally invasive techniques and local drug delivery will be “the wave of the future in sinus treatment”.

Propel, a mometason furoate implant, uses advanced corticosteroid with anti-inflammatory properties. It is inserted following endoscopic sinus surgery to stop the condition returning.

The spring-like implant expands to prop open the sinus and gradually delivers the medicine directly to the sinus tissue.

Chronic sinusitis often requires a combination of surgical and medical treatments.

It is a common condition where patients’ sinuses become swollen and inflamed, leading to difficulty in breathing, facial pain or headache, and reduced sense of smell and taste.

Each year, 500,000 US patients undergo sinus surgery to treat the condition, but the majority of patients experience recurrent symptoms within a year of surgery.

The FDA approval is based on results from three prospective clinical trials involving 205 patients in the US.

Intersect ENT is a company based in Palo Alto, California, and focuses on developing treatment alternatives to improve quality of life for ear, nose and throat patients.