Cross talk between medtech therapy teams here at DRG is always a pleasant surprise. Xi Chen on the Endoscopy team recently told me that there are stent and balloon devices for your nose. This reminded me of the stents and balloons in the interventional cardiology market my colleague on the Vascular team, Alexander Marsolais, researches.

So I got both of them in a room to see what these two markets can learn from each other.

Erik: Gentlemen, what do the stent and balloon devices in your markets treat? Is there a big market opportunity?

Alex: Within interventional cardiology, balloons and stents are the principle tools in the physicians toolkit, with stents increasingly the main workhorse and balloons playing an accessory role (in pre- and/or post-dilating the lesion). They are principally used in this indication to treat heart attacks, where a narrowed or blocked coronary artery is preventing blood flow to the heart muscle. Used together or separately, balloons and stents are designed to open up these arteries, and restore blood flow. It is a relatively big market (for example, there were something like 1 million such interventions in the US this year). While the outlook for patients has never been better, the market itself is pretty mature, with little growth in procedure volumes and generally falling prices over the past few years.

Xi: Chronic sinusitis affects about 13% of the population worldwide. It is a huge market for medical devices, even if you discount the majority of those 13% who will probably just receive medication or even no treatment at all. Functional endoscopic sinus surgery (FESS) is the most commonly used surgical technique to treat the more severe chronic sinusitis when medication has failed. Balloons have recently become a popular tool either to replace FESS or as an adjunct to FESS. On the other hand, the concept of sinus stenting goes back for decades but has been rarely used due to ineffectiveness. The drug-eluting sinus stent, however, entered the market just over a couple of years ago. These stents were used after FESS to improve surgical outcomes. In addition, there are a couple of stent variants in the pipeline that may expand the customer base beyond FESS patients. The potential for growth is enormous.

Erik: Is one device more effective than the other for either of the indications you research?

Alex: Stents definitely have an edge over balloons at this point in the IC space. Many years ago, before stents were introduced, it was common to perform what is called a ‘plain old balloon angioplasty’ or POBA for short (yes, doctors actually use this term!). However, the clinical data over the past 20+ years has clearly demonstrated that the use of a stent produces much better outcomes for patients, as patients treated only by POBA tend to suffer much higher rates of restenosis (where the targeted artery narrows again months or years after treatment).

Xi: The drug-eluting sinus stent is still new on the market. Besides, drug-eluting stents at present are not likely to be in direct competition with balloons per se because they are used for slightly different purposes. However, the new stent variants expected to come out in the near future will be in more direct competition with the balloon market. It will be exciting to see who comes out on top.

Erik: Alex, did stents enter the IC market after balloons like in chronic sinusitis?

Alex: Yes they did. The first POBAs were performed in the late 1970s, and had their heyday basically in the 1980s. Stents first started to appear in the late 1980s/early 1990s. The current leaders in most markets (including the US) are Abbott Laboratories, Boston Scientific and Medtronic – they have all been in this market for some time, are relatively entrenched, and tend to have somewhat equal shares in most geographies.

Erik: Xi, who is the leader in stents and balloons for the nasal market?

Xi: Acclarent (acquired by J & J) currently holds the majority of the shares in the balloon market due to first-mover advantage, however Entellus and Medtronic are growing very strong by offering some unique features. Intersect ENT is the only company with a FDA approved drug-eluting sinus stent; with two new products likely to be approved in the next 2-3 years, I don’t see Intersect ENT being challenged in the near future.

Erik: Well there you have it folks, two markets defined by stents and balloons: one mature, one in its infancy. I wonder if Acclarent, Entellus, Intersect ENT and Medtronic are reading up on the history of IC devices to see if something can be learned from the past.

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