Medtronic plc’s MDT NuVent EM sinus dilation system recently got an expanded indication clearance from the FDA. The approval will now allow this first-of-its kind balloon sinus dilation system to treat patients in need for revision sinus surgery (RSS).
Notably, the NuVent system was originally launched in the U.S., back in Aug 2014, to aid in minimally-invasive, balloon sinus surgery in patients suffering from chronic sinusitis. On account of the expanded clearance from the FDA, U.S. physicians can now use this system on patients on whom traditional sinus surgery has failed.
Sinusitis & Benefits of NuVent
Sinusitis is a common medical condition involving the inflammation of sinuses and nasal passages and it approximately affects 31 million U.S. citizens each year. Chronic sinusitis, an advanced stage of this disease affects approximately 15% of the U.S. population and is one of the most common chronic illnesses in America.
For those at the initial stage of the condition, medication is the most preferred treatment option. However, sinus surgery is generally reserved for chronic sinusitis patients who become unresponsive to drug therapy.
Traditional sinus surgery is a minimally-invasive procedure involving the removal of obstructive sinus tissues to improve natural nasal drainage. Still since sinus anatomy can vary widely among patients, surgical navigation plays an important role in sinus surgeries.
Interestingly, Medtronic’s NuVent is a unique balloon sinus dilation system incorporating a built-in electromagnetic (EM) surgical navigation technology, which enables a better view of one’s sinus anatomy and the optimal placement of balloons during surgery.
Furthermore, NuVent has been integrated to work with Medtronic’s image guidance technology called the Fusion ENT Navigation System, which acts like a GPS navigator in specifically targeting blocked sinuses during the sinus surgeries.
In the worst case scenario, often times the sinus surgery fails to cure the chronic sinusitis patient and can start posing unique challenges due to potential scar tissue and altered anatomy from the surgery. Subsequently, a revision surgery is performed on such patients.
The recent results of a prospective, single arm study conducted at investigational sites in the U.S., demonstrated the devices’ safety and effectiveness in successfully performing the revision surgery. This in turn earned this device the expanded indication clearance from FDA and thus is now allowed to perform surgery on sinusitis patients with scarred, granulated, or previously surgically-altered tissue.