Last week, the news broke that Cook Medical is recalling its Zilver PTX drug-eluting stents (DES)
, which had been so eagerly anticipated by US physicians following an incredibly arduous FDA approval process. Even at the time of the recall, it was only available in 85 US hospitals, leaving many physicians awaiting more widespread release. At the recent Society for Interventional Radiology (SIR) meeting, a couple of interventional radiologists were lamenting still not being able to get their hands on the device.
Approved in November 2012, this device was the first DES available in the US for peripheral indications and was approved for use in the femoropopliteal (fem-pop) arteries. By 2017, this product was anticipated to be used in nearly 27,000 procedures in the US alone.
The good news is that while this recall will create a bit of a dent in the Zilver PTX's 2013 global sales, it's unlikely to affect the 2017 projection. This is publicity that Cook Medical can ultimately get past the problem is with the delivery system rather than the stent itself, which is a plus. This kind of issue is not nearly as damaging to brand reputation as an issue directly related to the implantable stent would have been. Cook Medical has also already said that they've identified the problem component and have already amended the manufacturing process to address the issue. Therefore, besides the rollout of the stent being impacted in the short term, this will likely not have a major impact on the adoption of the Zilver PTX in the long term.
Once rollout of the Zilver PTX resumes, following the recall, price will remain the most important variable affecting adoption of the device. This is because there was still some question as to whether the premium price of the DES was justified compared to currently available revascularization options, with the speculation being that these products would primarily be used in reinterventions where other options have failed. This view is demonstrated in a few quotes from interventional radiologists and vascular surgeons interviewed by Millennium Research Group in late 2012.
-Reintervention would be the best [application for DES] from a cost standpoint. I probably won't [use DES] for primary interventions just because of the cost. A lot depends on where that price point falls compared with non-drug-eluting [stents].
Interventional Radiologist, US
-[If studies are able to] show significant improvement with regards to in-stent restenosis, then one may consider [using DES] as primary [treatment], but that will come after a lot of experience. [In the near future], balloon angioplasty will still be the front-line treatment. When angioplasty fails, or [for] in flow-limiting lesions such as dissections, then one may consider DES.
Vascular Surgeon, US
I do not see a role for DES. There is no good data that they really work. It's a marginal effect, but the cost is prohibitive. I don't see a major benefit.
Vascular Surgeon, US
So overall, yes, the recall isn?t a great thing for the Zilver PTX or Cook Medical. But they have bigger obstacles to overcome before this product becomes a standard part of every surgeon's toolkit anyway.