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DCB approved to treat US patients with PAD
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Spectranetics announced that the FDA approved its drug-coated balloon for endovascular treatment of patients with peripheral artery disease and superficial femoral or popliteal lesions.
The DCB (Stellarex) is the third approved for this indication in the United States. Approval was based on the results of the ILLUMENATE pivotal trial, which demonstrated high rates of patency and low rates of clinically driven target lesion revascularization in patients with a wide range of lesion complexity and comorbidities, according to a company press release.
“The Stellarex DCB has shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics and core-lab defined severely calcified lesions in the U.S. [investigational device exemption] trial,” Prakash Krishnan, MD, FACC, FSCAI, associate professor of medicine at Icahn School of Medicine at Mount Sinai and the co-principal investigator of the ILLUMENATE trial, said in the release. “These results, in combination with the cohort of patients studied in the European randomized controlled trial, demonstrate the Stellarex DCB is safe and effective in diverse patient populations when addressing symptomatic femoropopliteal disease.”
According to the release, the DCB’s hybrid paclitaxel crystallinity and durable excipient enable efficient drug transfer, enabling treatment with a low dose of paclitaxel.
Disclosure: Krishnan reports financial ties with Abbott Laboratories, C.R. Bard, Medtronic and Spectranetics.
Perspective
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Alik Farber, MD
This DCB has the same drug, paclitaxel, as the others on the U.S. market, Lutonix (C.R. Bard) and IN.PACT Admiral (Medtronic). The dose of the drug is similar to the Lutonix balloon but lower than the Admiral. It has a different carrier excipient that facilitates transfer of the drug to the vessel wall, using polyethylene glycol as opposed to polysorbate and sorbitol (Lutonix) and urea (Admiral). In the ILLUMENATE study, there was a higher percentage of patients with diabetes and/or calcified vessels than in the pivotal trials of the others and as such there is hope that this particular DCB may work well in calcified vessels.
Despite this promise, it is not clear how exactly this DCB will differ from the others. We have good evidence as to how DCBs compare against plain balloon angioplasty. However, this may not be as relevant a clinical question as which DCB is better overall, which is best for specific types of lesions, how the DCBs compare to drug-eluting stents, etc. There are many more questions that need to be answered in our quest to provide the best possible care for patients with PAD.
As more DCBs become available, we will be able to learn more about how they behave, both against one another and against other devices. As with most things, when another product is introduced, the competition and drive for knowledge increases. It’s a very positive development for all of us.
Finally, choosing a DCB not only involves clinical considerations, but administrative and cost considerations, as well. With multiple products on the U.S. market, I believe that many hospitals will push for physicians to choose one product, in an effort to consolidate contracts for endovascular hardware. The bright side is that there will be a clinical and research opportunity to determine which products work best for which types of clinical scenarios. More good data will lead to continued advances in patient care.
Having witnessed the endovascular revolution unfold over the past decade, it is exciting to see yet another endovascular device become available to physicians to treat patients with PAD.
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