Intersect ENT has announced it has received FDA approval of the company's second steroid-releasing product, according to a news release (pdf).
The PROPEL mini is designed for localized drug delivery and intended for patients suffering from chronic sinusitis.
The company's PROPEL mometasone furoate implant was approved by FDA last year. It is a spring-like implant inserted following endoscopic sinus surgery. PROPEL mini is a smaller version of PROPEL.
"We are excited that the significant clinical benefits of PROPEL will now be available to more patients suffering from chronic sinusitis, a condition that has a severe impact on quality of life," said Lisa Earnhardt, Intersect ENT's president and CEO, in the release. "PROPEL mini and PROPEL, clinically proven to maintain sinus patency after surgery, are the first and only products for patients undergoing sinus surgery to be backed by Level 1-A clinical evidence. Bringing two combination products to market in just over a year illustrates Intersect ENT's commitment to delivering meaningful products to our ENT customers and their patients."
PROPEL mini will initially be offered in select hospitals beginning this month, with a nationwide launch planned for 2013.
Intersect ENT is headquartered in Menlo Park, Calif.
Related Articles on FDA Clearances:
CareFusion Receives FDA Clearance for Take-Apart Laparoscopic Scissors
Teleflex Receives FDA Clearance for Reusable Obturators
Thermedical Receives FDA Clearance for Ablation System