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BD's Revello Stent Shows Strong AGILITY Trial Results for PAD Patients

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Key Takeaways

  • BD's Revello stent met the AGILITY trial's nine-month primary endpoint, with a failure rate of just 2.8%.
  • Trial showed 97.2% primary patency and 98.3% freedom from clinically driven target lesion revascularization.
  • BD's Revello stent remains investigational in the U.S., with clinical follow-up continuing through 36 months.

Becton, Dickinson and Company (BDX - Free Report) , popularly known as BD, recently reported positive nine-month results from the iliac cohort of the AGILITY trial evaluating its Revello Vascular Covered Stent for treating iliac artery disease, a form of peripheral artery disease (PAD). The findings, presented at VIVA 2026, showed promising safety and effectiveness and support continued clinical evaluation of the device.

The results are encouraging for BD as it seeks to strengthen its position in the peripheral vascular market through product innovation and clinical evidence. If subsequent follow-up confirms the device’s durability and effectiveness, Revello could expand BD’s growth opportunities in vascular intervention. Although Revello is CE-marked, it remains under clinical development in the United States and is limited to investigational use under U.S. law. Its commercial potential will depend on further clinical results and regulatory progress.

BDX Stock Trend Following the News

Following the announcement on Oct. 7, BDX stock has gained more than 2% till yesterday’s close. Year to date, shares of the company have lost 2.7% against the industry’s 9.5% growth and the S&P 500’s 12.5% rise.

The positive AGILITY trial results could support BDX’s long-term growth by strengthening its portfolio of peripheral vascular intervention products and expanding clinical evidence for the Revello Vascular Covered Stent. Favorable outcomes may improve physician confidence in the device and support its adoption if it secures the necessary regulatory approvals.

This could create an additional growth opportunity for BD in treating peripheral artery disease while complementing its broader vascular portfolio. However, long-term revenue contribution will depend on the completion of clinical follow-up, regulatory clearance in the United States and the device’s eventual commercial uptake.

BDX currently has a market capitalization of $51.63 billion.

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AGILITY Trial Demonstrates Strong Safety and Effectiveness

BD’s AGILITY Investigational Device Exemption trial evaluated the Revello Vascular Covered Stent in patients with iliac artery disease, which can restrict blood flow to the legs and feet, causing pain, cramping and reduced mobility. The iliac cohort enrolled 120 patients across 28 investigational sites in the United States, Europe, Australia and New Zealand. At nine months, the study met its primary composite safety and effectiveness endpoint, with a failure rate of just 2.8%, well below the prespecified performance goal of 19%.

The results also showed 97.2% primary patency, indicating that the treated arteries remained open. Trial data also demonstrated 98.3% freedom from clinically driven target lesion revascularization, suggesting a low need for repeat procedures due to clinical symptoms. Additionally, there were no device- or procedure-related deaths, no major amputations in the target limb at or above the ankle, or unanticipated serious adverse device effects. These findings support the stent’s performance in treating iliac artery disease, including cases involving moderate-to-severe lesion calcification.

Revello Stent Advances BD’s Peripheral Vascular Portfolio

The Revello Vascular Covered Stent is designed to combine the flexibility of a nitinol self-expanding stent with radial resistive force tailored to the iliac arteries. Beyond safety and vessel patency, patients treated in the AGILITY trial showed improvements in disease severity and walking ability. The mean Rutherford category, a measure of peripheral artery disease severity, improved from 3.0 at baseline to 0.3 at nine months, while the mean Walking Impairment Questionnaire score increased by 31.7 points.

Women accounted for approximately 41% of enrolled patients, adding to the diversity of the study population. Clinical follow-up in the iliac cohort will continue through 36 months to assess the durability of the results. BD also completed enrollment in the trial’s superficial femoral and proximal popliteal artery cohort in August 2026, extending the study’s evaluation of the device across additional peripheral vascular applications.

Continued positive results and progress toward regulatory approval could strengthen BD’s competitive position in peripheral intervention, although broader commercial adoption will depend on longer-term clinical outcomes and regulatory developments.

Industry Prospects Favoring the Market

Going by data provided by Grand View Research, the global iliac stent market size was valued at $1.2 billion in 2025 and is projected to grow from $1.3 billion in 2026 to $2 billion by 2033, at a CAGR of 6.5% from 2026 to 2033.

Growth of the market can be attributed to growing advancements in medical technology, increasing prevalence of peripheral artery diseases and expanding awareness about minimally invasive procedures as an effective treatment option.

Other News

BD recently advanced its pharmacy automation portfolio in the United States with the deployment of BD Vmax 160, its next-generation pharmacy automation robot at Fairview Health Services. The technology is designed to help high-volume centralized outpatient pharmacies manage the growing complexity of specialty and refrigerated medications while increasing fulfillment capacity and improving medication access.

BDX’s Zacks Rank & Key Picks

Currently, BDX carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are OPKO Health (OPK - Free Report) , Globus Medical (GMED - Free Report) and Merit Medical Systems (MMSI - Free Report) .

OPKO Health, currently flaunting a Zacks Rank #1 (Strong Buy), reported a second-quarter 2026 adjusted loss of 1 cent per share, which surpassed the Zacks Consensus Estimate by 87.5%. Revenues of $163.6 million beat the Zacks Consensus Estimate by 24.7%. You can see the complete list of today’s Zacks #1 Rank stocks here.

OPK has an estimated earnings growth rate of 23.3% for 2026. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 95.1%.

Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported a second-quarter 2026 adjusted earnings per share (EPS) of $1.34, which surpassed the Zacks Consensus Estimate by 19.6%. Revenues of $789.6 million beat the Zacks Consensus Estimate by 0.4%.

GMED has an estimated long-term earnings growth rate of 12.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.9%.

Merit Medical Systems, carrying a Zacks Rank #2 at present, reported second-quarter 2026 adjusted EPS of $1.19, which beat the Zacks Consensus Estimate by 23.9%. Revenues of $418.8 million surpassed the Zacks Consensus Estimate by 3.5%.

MMSI has an estimated long-term earnings growth rate of 10.4%. MMSI’s earnings surpassed estimates in the trailing four quarters, with the average surprise being 14.1%.

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