Intersect have received the FDA seal of approval of their targeted drug delivery technology for treatment in chronic sinusitis patients.
The device – Propel, a novel implantable delivery system for mometasone furoate – offers controlled delivery of steroid medication directly to sinus mucosa.
Once inserted using endoscopic surgery, the bioabsorbable spring-like impant expands to prop open the sinus then gradually delivers an advanced corticosteroid with anti-inflammatory properties directly to the lining.
Intersect say Propel is the first of a new category of products offering localized, controlled delivery of steroid directly to the sinus tissue.
Lisa Earnhardt, the Palo Alto-based company’s president and CEO, said: “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.
“We look forward to launching our product to clinicians and their patients in select US locations this fall.”
Invasion of the implant
Chronic sinusitis is a condition in which patients' sinuses become swollen and inflamed, which can lead to difficulty breathing, facial pain or headache, and reduced sense of smell and taste.
Previous therapies include a combination of surgical and medical treatments, and more than 500,000 patients undergo sinus surgery each year to correct the problem.
However unlike surgery, in which symptoms can recur, Intersect says its clinical trials have proven the novel implant device will maintain sinus patency.
Results also showed a reduced need for additional operation and the use of systemic steroids that can have serious side effects, and will speed-up healing time.
David Kennedy, professor of Otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, said of the FDA’s (US Food and Drug Administration) decision to OK the technology: “The FDA approval of this innovative new product is great news for ENT clinicians and patients.
“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.”