Peripheral Artery Disease

Peripheral artery disease (PAD) involves atherosclerosis mainly in the extremities, especially in the legs and feet that lead to ischemia. Untreated, PAD can progress to critical limb ischemia (CLI), also called chronic limb-threatening ischemia (CLTI), which will lead to foot or leg amputation. The mortality rate for these CLI amputees is 70% within three years. There is currently an epidemic of PAD and CLI in the U.S. The majority of patients are defined by health disparities concentrated in the Black, Latino, Native American populations in both rural and low-income urban areas. A large number of PAD patients have other comorbities, with diabetes being one a primary issue.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

Cardiologists help highlight ‘severe consequences’ of peripheral artery disease

Many PAD patients do not even know they have the disease until it is too late, leading to unnecessary amputations and increasing the risk of other adverse patient outcomes. Awareness is especially limited among Black and Hispanic adults, experts warn, creating an added sense of urgency when looking to accelerate patient education efforts.

Black, rural and low-income PAD patients are less likely to receive high-quality care

"This research should be a call to health systems, policymakers and other stakeholders to make it easier for patients—especially the most vulnerable patients—to access PAD-specific care," one cardiologist explained. 

Philips Healthcare's combined IVL and laser atherectomy catheter that is being used in the THOR trial to treat heavily calcified peripheral artery lesions.

Intravascular lithotripsy technology now a top priority for many healthcare companies

After the significant success of Shockwave Medical's IVL therapy to break up heavily calcified vessels without trauma, there are now several companies working on their own IVL devices. 

Society Society for Cardiovascular Angiography and Interventions (SCAI) President James Hermiller, MD, discusses achievements of SCAI in 2024. #SCAI

SCAI president reviews achievements in interventional cardiology in 2024

SCAI President James Hermiller, MD, recently outlined the key achievements for 2024, including creation of the first interventional cardiology match program, successful advocacy and efforts to increase women in the field.

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Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

Video interview with J.D. Corl, MD, explaining the use of the new E8 and Javelin Shockwave IVL catheters in PAD.

New balloonless IVL catheter offers an alternative to atherectomy in tight lesions, CTOs

J.D. Corl, MD, shared his experience using two new IVL catheters from Shockwave Medical to treat patients with heavily calcified peripheral arteries. He considers both new devices a significant upgrade. 

The Abbott Esprit BTK everolimus-eluting biosorbable scaffold system for below the knee peripheral artery disease on display at TCT 2024. Photo by Dave FornellTCTn 2024 DF

Bioresorbable BTK stent superior to ballon angioplasty at 2 years

Late-breaking data from the LIFE-BTK clinical trial showed that the Esprit BTK bioresorbable scaffold system offered better two-year outcomes than balloon angioplasty in severe peripheral artery disease (PAD) below the knee.

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