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The peripheral artery disease (PAD) treatment market is on fire, and BD (Becton, Dickinson and Company) is positioning itself to seize the lead. With its Rotarex™ Atherectomy System and the newly launched XTRACT Registry,
is betting big on a strategic initiative that could cement its dominance in a $5.6 billion market projected to grow at 6.8% annually through 2030. This isn't just about innovation—it's about owning the narrative on clinical efficacy and safety in a space where outcomes matter most.
PAD affects over 200 million people globally, and as populations age, this number is soaring. The disease—often caused by plaque buildup in leg arteries—is a major driver of amputations and cardiovascular events. But here's the kicker: only 30% of PAD patients receive timely intervention. That leaves a massive untapped market for therapies like atherectomy, which mechanically removes plaque.
BD's Rotarex™ system is a star player here. Unlike competing tools like drug-coated balloons or lithotripsy devices, Rotarex combines atherectomy and thrombectomy in one procedure, tackling both plaque and blood clots. But why the XTRACT Registry? Because in 2025, data is king—and BD is weaponizing its research to win over doctors and insurers.
Launched this year, the XTRACT Registry is a prospective, multi-center study enrolling 600 U.S. patients to assess real-world outcomes of Rotarex. This isn't just a compliance check—it's BD's blueprint to:
1. Validate efficacy: By tracking 12-month outcomes, including freedom from restenosis and amputation rates, BD can prove Rotarex's superiority in complex cases like chronic total occlusions (CTOs).
2. Counter safety concerns: After the FDA's 2024 Class I recall over helix fractures, the registry will demonstrate how updated procedural guidelines (like using kink-resistant sheaths) eliminate risks and boost safety.
3. Drive reimbursement: Medicare and private insurers are watching. Positive data here could push Rotarex to the top of the preferred device list, especially as the OIG investigates overbilling in PAD procedures.
Atherectomy adoption has skyrocketed—from 8.5% of PAD procedures in 2019 to 19.7% in 2020—and Rotarex is already a top choice for complex cases. With the XTRACT Registry delivering U.S.-specific data, BD can lock in partnerships with hospitals and vascular centers hungry for tools that reduce revascularization rates.
The FDA recall was a red flag, but BD's response—updating instructions, training surgeons, and emphasizing anatomical precautions—turned a potential disaster into a credibility win. Investors should note: the recall didn't halt sales. BD's corrective action shows it's proactive, not reckless.
Imagine this: By Q4 2026, XTRACT data shows Rotarex patients have 90% freedom from reintervention at 12 months—beating DCBs and lithotripsy. That's a firehose of growth. BD's Rotarex could become the gold standard for PAD, especially in high-risk patients where other devices fall short.
Critics will point to competition (Shockwave's lithotripsy, Medtronic's drug-coated stents) and reimbursement battles. But here's the truth: no one else has a registry this bold. BD is stacking the deck with data that could make Rotarex indispensable.
The PAD market is primed for disruption, and BD is out in front with a device and data strategy that's designed to win. With XTRACT's results coming in 2026 and a 25-year legacy of innovation, this is a “set it and forget it” stock for investors.
Act now—because when the PAD gold rush hits, you'll want to be holding BD shares.
Disclosure: This is not personalized financial advice. Consult your advisor before investing.
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