Intersect ENT Announces FDA Approval of New PROPEL Mini Straight Delivery System
PROPEL Mini Delivery System Designed to Facilitate Implant Placement in the Ethmoid Sinus
MENLO PARK, Calif. — Intersect ENT®, Inc. (Nasdaq:XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the company has received approval from the U.S. 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.
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.
About Intersect ENT®
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.
For additional information on the company or the products including risks and benefits please visit www.IntersectENT.com.
Intersect ENT and PROPEL are registered trademarks of Intersect ENT, Inc.
IMPORTANT SAFETY INFORMATION FOR PROPEL FAMILY OF SINUS IMPLANTS
INDICATIONS FOR USE
The PROPEL Mini sinus implant is intended for use in patients ≥ 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. The PROPEL Mini sinus implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. Patients allergic to the drug (mometasone furoate) or ingredients of the implant should not receive PROPEL. It is not known if the implant is safe and effective in women that are pregnant or nursing. Common side effects include infection, headache, and nose bleeds. Risks related to the implant include pain/pressure, movement of the implant (within or out of the sinus) and potential side effects of steroids. For more information on the risks and benefits of PROPEL Mini sinus implant, talk to your doctor or review the FDA approved labeling at www.IntersectENT.com/technologies/. Rx only.
This release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “promises,” “predicts,” “believes,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These statements include those related to the safety, efficacy and patient and physician adoption of SINUVA. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation the company’s ability to procure and maintain required regulatory approvals for our products and the adoption of SINUVA and the company’s other therapies by physicians and patients, as well as other risks detailed from time to time in Intersect ENT’s filings with the Securities and Exchange Commission (SEC), including Intersect ENT’s filings on Form 10-K and Form 10-Q available at the SEC’s Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
View source version on businesswire.com: