ICYMI: Paclitaxel Device Market Rebounding

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ARTICLE SUMMARY:

As reassuring safety data on the use of paclitaxel devices in the periphery continues to mount, this market has started to show some signs of recovery. Moreover, there are encouraging signs on the regulatory and reimbursement fronts as well, with several new device approvals/positive reimbursement decisions.

Data from the 6,500-patient VOYAGER PAD study presented at this year’s virtual Transcatheter Cardiovascular Therapeutics meeting, held in mid-October, strongly suggest that safety fears over the use of paclitaxel-coated balloons and stents in the periphery should be put to rest. Safety concerns have had a chilling effect on the drug-coated device (DCD) market, as providers worldwide pulled back from what was a robustly growing interventional device segment.

According to iData Research, annual unit sales of drug-coated balloons fell by about 20% in Europe and 40% in the US in 2019, while peripheral vascular drug-eluting stent (DES) use declined by about 9% in Europe and 11% in the US.

There are currently five manufacturers competing in this segment in the US, two with peripheral vascular DES—Boston Scientific Corp. (Eluvia) and Cook Medical Inc. (Zilver)—and three with paclitaxel drug-coated balloons (DCBs) approved for use in the vessels above the knee: Medtronic plc. (IN.PACT Admiral), BD/Bard (Lutonix), and Philips Medical, with Stellarex, a low-dose (2ug/mm2) DCB that was FDA approved in October 2019. Boston Scientific received FDA approval for its Ranger 2ug/mm2 paclitaxel coated peripheral DCB on October 30, 2020; the device was CE marked in 2014.)

As reassuring safety data on the use of paclitaxel devices in the periphery continue to mount, this market has started to show some signs of recovery, with device sales on the rise in recent quarters and iData now anticipating a “healthy market recovery” within five to seven years. Moreover, there are encouraging signs on the regulatory and reimbursement fronts as well, with several new device approvals/positive reimbursement decisions.

In addition to Stellarex’ October 2019 US approval, in November 2019, Medtronic, an early leader in the DCB field, received FDA approval for its IN.PACT AV paclitaxel-coated DCB, used to treat failing arteriovenous (AV) access grafts in patients with end-stage renal disease. FDA’s October approval for Boston Scientific’s Ranger took an unusually long time—15 months—likely because of the paclitaxel safety issue. But it is another indication that new study data may be putting those safety fears to rest.

BSX is now the only US competitor marketing both a paclitaxel drug-eluting stent (Eluvia) and a paclitaxel drug-coated balloon for peripheral artery disease. (CMS recently granted Eluvia a fiscal 2021 new technology Medicare add-on payment in the inpatient setting, reversing an earlier denial due to the paclitaxel safety issue.)

According to Larry Biegelsen of Wells Fargo Securities, writing in a recent note, “the overall category of paclitaxel-coated devices for PAD is poised for a comeback given (1) the recent positive safety data and (2) the imperative to reduce the need for additional procedures due to the pandemic” (drug-coated balloons and stents reduce the need for repeat procedures compared to uncoated devices). Biegelsen expects worldwide Eluvia and Ranger sales to ramp up fairly quickly, from $68 million in 2020 to $327 million by 2025, with sales of Eluvia outpacing Ranger due to the more favorable reimbursement situation (with the new add-on payment) and the less-crowded competitive field for peripheral stents.

There are encouraging regulatory signs in Europe as well. In June, Surmodics Inc. received a CE mark for its paclitaxel coated SurVeil DCB, which is commercially licensed to Abbott Laboratories Inc. Surmodics’ US pivotal trial, TRANSCEND, is comparing the SurVeil device head-to-head against Medtronic’s IN.PACT Admiral DCB—Surmodics hopes to file a PMA submission for US approval sometime in fiscal 2021. No doubt physicians will be watching the results of Surmodics’ US trial carefully, as several at TCT called on manufacturers to conduct head-to-head studies to help determine which DCB devices work best in which patients.

Meanwhile, others are developing non-paclitaxel-coated balloons and stents for use in the periphery, including Concept Medical Inc., which received a CE mark in October 2019 for its sirolimus-coated MagicTouch DCB for AV applications.

Excerpted from “The Paclitaxel Drug-Coated Device Controversy: Case Closed?” MedTech Strategist, October 30, 2020.

 

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