BD Strengthens Leadership in Peripheral Vascular Innovation with Positive AGILITY Trial Results

The nine-month endpoint failure rate was 2.8%, significantly below the trial's prespecified 19% performance goal.

Rhea-AI Summary

BD (NYSE: BDX) announced nine-month AGILITY trial results showing its Revello Vascular Covered Stent met the primary endpoint in iliac artery disease.

The cohort enrolled 120 patients at 28 sites. The combined safety and effectiveness endpoint had a 2.8% failure rate, significantly below the prespecified 19% performance goal. Primary patency, meaning treated arteries remained open, was 97.2%; freedom from clinically driven repeat treatment of the target lesion was 98.3%. There were no device- or procedure-related deaths, target limb major amputations or unanticipated serious adverse device effects. Mean Rutherford disease-severity category improved from 3.0 to 0.3, and the mean walking impairment questionnaire score rose 31.7 points from baseline.

Follow-up continues through 36 months. Enrollment in a separate leg-artery cohort finished in August. Revello is CE marked but remains limited to investigational use in the United States.

8 points · 1 major

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0 major · 0 points

How the balance works

Positive

• Major pointPrimary composite endpoint met with 2.8% failure through nine months, significantly below the 19% prespecified performance goal.
• Minor point97.2% primary patency through nine months showed treated arteries remained open.
• Minor point98.3% freedom from clinically driven target lesion revascularization through nine months indicated limited repeat treatment.
• Minor pointNo device- or procedure-related deaths, target limb major amputations or unanticipated serious adverse device effects through nine months.
• Minor pointMean Rutherford category improved from 3.0 at baseline to 0.3 at nine months.

3 minor points

• Minor pointMean walking impairment questionnaire score improved by 31.7 points from baseline to nine months.
• Minor pointSuperficial femoral and proximal popliteal artery cohort enrollment completed in August.
• Minor pointRevello Vascular Covered Stent is CE marked.

Negative

• None.

Key Figures

Iliac cohort enrollment: 120 patients; 28 sites Composite endpoint failure rate: 2.8% vs. 19% Primary patency: 97.2% +4 more

Iliac cohort enrollment

120 patients; 28 sites

AGILITY iliac cohort

Composite endpoint failure rate

2.8% vs. 19%

Nine-month results; prespecified performance goal was 19%

Primary patency

97.2%

Through nine months

Freedom from target lesion revascularization

98.3%

Clinically driven; through nine months

Specified safety events

0

No device- or procedure-related deaths, target limb major amputations, or unanticipated serious adverse device effects

Mean Rutherford category

3.0 at baseline to 0.3

Through nine months

Mean WIQ score change

31.7 points

Improvement from baseline to nine months

Key Terms

investigational device exemption, primary patency, target lesion revascularization, nitinol, +1 more

5 terms

investigational device exemption regulatory

"AGILITY Investigational Device Exemption trial evaluating the Revello™ Vascular Covered Stent."

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

primary patency medical

"97.2% primary patency"

Primary patency is the length of time a blood vessel or vascular access remains open after an initial procedure (such as angioplasty, stent placement, or graft implantation) without any additional surgical or endovascular interventions to re-open it. It is measured as freedom from restenosis or occlusion and from any repeat procedure at the treated site; related terms are assisted primary patency (patency maintained by prophylactic or preventive procedures without prior thrombosis) and secondary patency (vessel reopened after it has occluded).

target lesion revascularization medical

"98.3% freedom from clinically driven target lesion revascularization"

Repeat medical or surgical procedure performed to reopen or treat the exact arterial narrowing (the previously treated lesion) that received an earlier revascularization; it includes repeat percutaneous or surgical interventions done because the same lesion has become narrowed or blocked again. Clinical and regulatory definitions commonly specify anatomical boundaries (for example, the stent or grafted segment plus short margins) and whether the repeat procedure must be prompted by symptoms or objective evidence of ischemia, so the precise inclusion rules depend on the trial or reporting standard. Distinct from target vessel revascularization, which covers any reintervention anywhere in the same blood vessel, target lesion revascularization is limited to the originally treated lesion site.

nitinol technical

"the flexibility of a nitinol self-expanding stent"

Nitinol is a nickel‑titanium metal alloy known for “shape memory” and spring‑like flexibility: it can return to a preset shape after bending or heating, like a paperclip that snaps back when warmed. Investors track it because those unique properties make it a go‑to material for medical implants, surgical tools and precision devices, so changes in availability, cost, regulation or technical advances can directly affect manufacturers’ product performance, margins and regulatory risk.

peripheral artery disease medical

"a common form of peripheral artery disease (PAD)."

A circulatory condition in which arteries that supply blood to the legs and feet become narrowed or blocked, reducing blood flow and causing pain, slow healing, or tissue damage—think of it as clogged pipes in the body’s lower limbs. It matters to investors because the prevalence, available treatments, and clinical trial or regulatory outcomes shape demand for drugs, devices, and care services, which can affect revenues, costs and valuation in healthcare-related businesses.

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Data through 9 months of follow-up from this ongoing 36-month study demonstrate high vessel patency, low reintervention rates and meaningful improvements in mobility and symptoms, providing evidence supporting the treatment of complex iliac artery disease.

FRANKLIN LAKES, N.J., Oct. 7, 2026 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced positive nine-month results from the iliac cohort of the AGILITY Investigational Device Exemption trial evaluating the Revello™ Vascular Covered Stent. Presented at VIVA 2026 by Sean Lyden, M.D., global lead principal investigator for AGILITY, the results demonstrated strong safety and effectiveness outcomes in patients with iliac artery disease, a common form of peripheral artery disease (PAD). The findings mark an important milestone in the efforts by BD to expand clinical evidence supporting innovative solutions for chronic vascular disease and reinforce its commitment to advancing care for patients with PAD.

The study met its primary composite endpoint for the treatment of iliac artery disease and adds to the growing body of clinical evidence supporting the continued evaluation of the Revello™ Vascular Covered Stent. The device is designed to combine the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries.

Iliac artery disease can reduce blood flow to the legs and feet and potentially cause symptoms such as leg pain, cramping, impaired mobility and reduced quality of life. As treatment options evolve, physicians continue to seek durable solutions that provide sustained vessel patency and favorable long-term outcomes, particularly for patients with complex iliac artery anatomy.

The AGILITY iliac cohort enrolled 120 patients at 28 investigational sites in the United States, Europe, Australia and New Zealand. Through nine months of follow-up, treatment with the Revello™ Vascular Covered Stent resulted in:

• Composite safety and effectiveness endpoint met with a failure rate of 2.8%, significantly below the 19% prespecified performance goal
• 97.2% primary patency
• 98.3% freedom from clinically driven target lesion revascularization
• No device- or procedure-related deaths, target limb major amputations (at or above the ankle), or unanticipated serious adverse device effects

Patients experienced meaningful gains in daily function and mobility, with mean Rutherford category improving from 3.0 at baseline to 0.3 and mean WIQ score improving by 31.7 points from baseline to 9 months. Women represented approximately 41% of enrolled patients, and slightly more than half of lesions showed moderate-to-severe calcification.

"These latest data showed high primary patency and low clinically driven target lesion revascularization in a patient population that included both straightforward and complex iliac lesions," said Sean Lyden, M.D., chairman of the Department of Vascular Surgery at Cleveland Clinic and global lead principal investigator for AGILITY. "Results showed the treated arteries remained open in a high percentage of patients, and at nine months, patients also showed changes in disease severity and walking ability."

"These results reflect the continued commitment of BD to advance evidence-based innovation in peripheral vascular care," said Rob Righi, vice president and general manager of the Vascular Platform, Peripheral Intervention at BD. "As follow-up continues, the AGILITY study will help further characterize the Revello™ Vascular Covered Stent's performance across patients with peripheral artery disease."

Clinical follow-up in the iliac cohort is ongoing through 36 months. BD also completed enrollment in the study's superficial femoral and proximal popliteal artery cohort this past August, marking another milestone in the AGILITY study.

The Revello™ Vascular Covered Stent is CE marked. In the United States, the Revello™ Vascular Covered Stent is an investigational device limited by U.S. law to investigational use only.

About BD
BD is one of the world's largest pure-play medical technology companies with a Purpose of advancing the world of health™ by driving innovation across medical essentials, connected care, biopharma systems and interventional. The company supports those on the frontlines of healthcare by developing transformative technologies, services and solutions that optimize clinical operations and improve care for patients. Operating across the globe, with more than 60,000 employees, BD delivers billions of products annually that have a positive impact on global healthcare. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand access to healthcare. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X @BDandCo or Instagram @becton_dickinson.

Contacts:
Media	Investors
Matt Marcus VP, Public Relations Matt.Marcus@bd.com	Shawn Bevec SVP, Investor Relations Investor_Relations@bd.com

 

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SOURCE BD (Becton, Dickinson and Company)

FAQ

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What did BD's AGILITY iliac artery trial show at nine months?

The trial met its primary composite safety and effectiveness endpoint, with a 2.8% failure rate versus the prespecified 19% performance goal. Primary patency was 97.2%, and freedom from clinically driven target lesion revascularization was 98.3% through nine months.

How many patients with complex lesions participated in BD's AGILITY iliac cohort?

Slightly more than half of lesions showed moderate-to-severe calcification. The iliac cohort enrolled 120 patients across 28 investigational sites in the United States, Europe, Australia and New Zealand; women represented approximately 41% of enrolled patients.