FDA Okays Medtronic's NuVent For Expanded Use In Sinusitis

Medtronic plc’s (NYSE: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.

Our Take

With chronic sinusitis being a widespread medical condition, Medtronic’s ingenious surgical tool – the NuVent system – surely comes as a boon for patients who continue to suffer from the symptoms even after undergoing the sinus surgery and therefore need to undergo a revised one.

While performing a revised sinus surgery, often the physicians face technical challenges particularly associated with the frontal sinus. Encouragingly, though NuVent now offers a 70° angled frontal probe, which is a familiar angle for sinus surgery, coupled with the Fusion navigation system.

Not only does this device overcome the technical challenges involved with the revised surgery thereby improving outcomes for concerned patients, but also effectively reduce their out-of-pocket costs when the procedure is performed in a physician’s office. As insurance companies, usually do not reimburse the patients for undergoing in-office surgical procedures, making this device also a cost-effective one.

Of late, the management has witnessed a stronger mid single-digit growth in the U.S. outpatient surgery market, which in turn boosted the company’s revenue growth in Minimally Invasive Therapies Group. With the minimally invasive surgical instruments market projected to reach $18.1 billion by 2021, at a CAGR of 10.2% from 2016, we expect the recent FDA approval for its NuVent system will surely increase Medtronic’s shares in this market as well as its MITG revenue.

Zacks Rank

Medtronic currently holds a Zacks Rank #3 (Hold). Some better-ranked medical stocks are GW Pharmaceuticals plc (NASDAQ:GWPH) , Nxstage Medical, Inc. (NASDAQ:NXTM) and TG Therapeutics, Inc. (NASDAQ:TGTX) . All these stocks sport a Zacks Rank #1 (Strong Buy).