Intersect ENT Announces U.S. FDA Approval for First Drug Releasing Implant for Chronic Sinusitis Patients
Breakthrough Treatment Improves Outcomes for Sinus Surgery
Intersect ENT, Inc., an innovator in treatment alternatives for ear, nose and throat clinicians and patients, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Pre-market Approval (PMA) application for the Propel™ mometasone furoate implant offering localized, controlled drug delivery for chronic sinusitis patients.
Chronic sinusitis is a condition in which patients’ sinuses become swollen and inflamed, leading to difficulty breathing, facial pain or headache, and reduced sense of smell and taste. The condition is common, affecting one in seven adults in the U.S., and greatly impacts quality of life. Chronic sinusitis often requires a complex combination of surgical and medical treatments. Each year, 500,000 patients undergo sinus surgery to treat the condition. Although sinus surgery is effective, the majority of patients experience recurrent symptoms within the first year; as many as 25 percent then undergo revision surgery due to recurrent obstruction of the sinus cavity.
Propel is the first of a new category of products offering localized, controlled delivery of steroid directly to the sinus tissue. Inserted by a physician following endoscopic sinus surgery, the spring-like implant expands to prop open the sinus and gradually delivers an advanced corticosteroid with anti-inflammatory properties directly to the sinus lining to maintain sinus patency.
The Propel system has been clinically proven to prevent obstruction of the ethmoid sinus following surgery. The result is improved post-operative outcomes, reducing the need for additional surgical procedures and systemic steroids that can have serious side effects.
“The FDA approval of this innovative new product is great news for ENT clinicians and patients,” said David W. Kennedy, MD, FACS, professor of Otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, PA, a widely recognized pioneer in functional endoscopic sinus surgery. “Propel reduces the occurrence of inflammation and scarring in the post-operative period. As a result, it promises to substantially improve long-term outcomes for sinus surgery and, as my research has demonstrated, reduced scarring and inflammation correlates with absence of the need for further surgery. I believe the combination of minimally invasive techniques and local drug delivery will be the wave of the future in sinus treatment.”
“The FDA approval of Propel marks an exciting milestone for Intersect ENT as well as sinus sufferers and their physicians who will now have an important new treatment option, clinically proven to maintain the benefits of sinus surgery,” said Lisa Earnhardt, the company’s president and CEO. “We look forward to launching our product to clinicians and their patients in select US locations this fall.”