Medtronic ($MDT) has launched NovaShield Injectable Nasal Packing and Stent for functional endoscopic sinus surgery (FESS) after an FDA clearance in October. It's a gel made from chitosan that's placed in the sinus or nasal cavities after the surgery. Unlike traditional sponge or gauze packing, NovaShield does not need to be removed while it's whole, a process that can be painful for patients.
Chitosan is a polymer produced from chitin, a component of the external shell of shellfish that has properties that enhance bleeding control. This is Medtronic's first chitosan-based packing; its use is associated with fast hemostasis with fewer adhesions even in patients taking antiplatelet or anticoagulant medications that make this process more difficult.
"Nasal packing is an important factor in postoperative care and the ultimate outcome of sinus surgery," Vince Racano, VP and GM of the ENT business at Medtronic, said in a statement. "We're excited to bring sinus surgeons this convenient new tool for FESS."
NovaShield has shown antibacterial activity in vitro, but Medtronic is quick to caution that this hasn't translated into improved clinical effectiveness.
Medtronic also markets bioresorbable FESS nasal packing MeroGel and MeroPack, which are comprised of esterified hyaluronic acid, a naturally occurring constituent of the extracellular matrix that helps keep wounds moist, reduce adhesions, and decrease healing time, according to the company.
All these products are part of Medtronic's ear, nose and throat (ENT) business within its Surgical Technologies group. Medtronic's ENT business gained in the "upper-single digits" due to the launches of M5 Microdebrider, monitoring disposables and NuVent sinus balloon, the company said on its most recent earnings call in November.
That helped to make Surgical Technologies one of the top performing groups during Medtronic's fiscal second quarter that ended Oct. 24 with 10% growth to $410 million from the same quarter a year prior.
Almost 29 million U.S. adults have chronic sinusitis, with more than 525,000 FESS procedures performed annually. Common surgical complications include bleeding and adhesions, or scars, which can block the sinuses and potentially cause disease recurrence and necessitate additional surgery.
- here is the release
Editor's Note: The story is corrected to reflect the correct regulatory approval status.