Intersect ENT, a company dedicated to transforming care for patients with ear, nose and throat conditions, announced that the company has received approval from the US Food and Drug Administration (FDA) for a new Straight Delivery System (SDS) for use to place its PROPEL® Mini steroid releasing sinus implant in the ethmoid sinus.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
PROPEL Mini helps maintain the sinus opening while delivering mometasone furoate directly where it is needed, improving outcomes of frontal (behind the forehead) and ethmoid (behind the bridge of the nose) sinus surgery.
The new SDS is designed to help physicians achieve precise and easy delivery of the PROPEL Mini implant to the ethmoid sinus. The original curved delivery system will continue to be packaged with the PROPEL Mini sinus implant and used for implant delivery to the frontal and ethmoid sinuses.
“We listened to feedback from physicians offering PROPEL Mini to their patients, and we are pleased to deliver this new delivery system, developed specifically with ease of use and overall procedure time in mind,” said Tom West, president and CEO of Intersect ENT.
“The Straight Delivery System provides physicians with another opportunity to customize treatment to achieve the best possible patient results.”
“The new Straight Delivery System is designed to help me accurately deploy the PROPEL Mini implant into the ethmoid sinus without adjustments or secondary placements,” said Arjuna Kuperan, M.D., a rhinologist and board-certified otolaryngologist at Houston Advanced Nose & Sinus. “It is practical for placing the PROPEL Mini stent at the precise location where it is intended.”
The company expects to make the SDS available to physicians during the third quarter of 2019.
Intersect ENT is dedicated to transforming ear, nose and throat care by providing innovative, clinically meaningful therapies to physicians and patients. The company’s steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease.
In addition, Intersect ENT is continuing to expand its portfolio of products based on the company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.
Source: Company Press Release