News | January 23, 2014

Drug-Coated Device Opens Peripheral Arteries, Dissolves

Six-month results of ESPRIT trial promising

Espirt Bioresorbable Vascular Scaffold BVS Peripheral Artery Disease PAD

January 23, 2014 – Six-month results of the ESPRIT trial suggest a bioresorbable drug-eluting scaffold is effective in opening blocked blood vessels in the legs and pelvis, as presented at the 26th annual International Symposium on Endovascular Therapy (ISET). 

The bioresorbable vascular scaffold (BVS) looks and works like a stent to open blocked arteries in the legs or pelvis, and the drug coating prevents restenosis. The BVS is called a scaffold rather than a stent because it is a temporary structure that naturally dissolves into the blood stream within 18 months to two years.

 
“We’re seeing zero restenosis in the first patients to receive the BVS in the peripheral arteries, the vast majority of whom suffered moderate to severe pain while walking prior to treatment and had very little to no pain after treatment,” said Johannes Lammer, M.D., professor of radiology and director of the Division of Cardiovascular and Interventional Radiology at the Medical University of Vienna, Austria. “The BVS…opens arteries and prevents restenosis, then resorbs into the blood stream so there are no stent breaks, no prolonged irritation or delayed in-stent restenosis and no interference with magnetic resonance imaging or surgery.”
 
In the study of the Esprit BVS, 35 patients were treated for blockages averaging about 3.5 cm. Four patients had blockages in the pelvic iliac arteries and 31 in the superficial femoral artery. Six months after treatment, all of the arteries in the 34 patients who were followed remained open, with the narrowing reduced from an average of 80 percent prior to treatment to 13 percent after treatment. 
 
Prior to treatment, 32 patients (91 percent) had moderate to severe pain while walking, and no patients were pain-free. Six months after treatment, 29 patients (85 percent) had no pain while walking, and only one (3 percent) had moderate pain.
 
The BVS is made of polylactide, which naturally resorbs in the blood stream and has been shown to be safe in other medical uses, such as for dissolving stitches. A version of the device has been used to treat blocked heart arteries.
 
For more information: www.iset.ge

Related Content

Intact Vascular Inc. received U.S. Food and Drug Administration (FDA) market clearance for the Tack Endovascular System. This is a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD).
Technology | Peripheral Artery Disease (PAD) | April 15, 2019
April 15, 2019 – Intact Vascular Inc. received U.S.
The Boston Scientific Eluvia self-expanding, drug-eluting peripheral stent. It outperformed the Cook Zilver stent in the IMPERIAL Trial presented at TCT 2018.

The Boston Scientific Eluvia self-expanding, drug-eluting peripheral stent. It outperformed the Cook Zilver stent in the IMPERIAL Trial presented at TCT 2018.

Feature | Peripheral Artery Disease (PAD) | January 30, 2019 | Dave Fornell, Editor
In recent years, there has been a lot of focus by vendors on developing better stenting technologies to treat...
The safety of paclitaxel-eluting stents and drug-coated balloons was called into question in a recent study that showed higher mortality rates after two years. The Cook Zilver PTX paclitaxel-eluting peripheral stent is among the devices included in that study.

The safety of paclitaxel-eluting stents and drug-coated balloons was called into question in a recent study that showed higher mortality rates after two years. The Cook Zilver PTX paclitaxel-eluting peripheral stent is among the devices included in that study.

Feature | Peripheral Artery Disease (PAD) | January 25, 2019 | Dave Fornell, Editor
The anti-proliferative drug paclitaxel has been used as a coating on coronary stents to prevent restenosis since 2003
Lumee Oxygen Platform Measures Treatment Response in Critical Limb Ischemia
News | Peripheral Artery Disease (PAD) | January 25, 2019
January 25, 2019 — Profusa announced promising...
BEST-CLI Trial Examining Critical Limb Ischemia Treatment Options Nears Enrollment Goal
News | Peripheral Artery Disease (PAD) | January 23, 2019
A new report in the Journal of Vascular Surgery chronicles a multi-site randomized controlled trial comparing treatment...
FDA Issues Letter About Paclitaxel Coated Balloons and Eluting Stents
News | Peripheral Artery Disease (PAD) | January 17, 2019
The U.S. Food and Drug Administration (FDA) issued a letter Jan. 17, 2019, to healthcare providers regarding a recent...
New Appropriate Use Criteria Released for Peripheral Artery Interventions
News | Peripheral Artery Disease (PAD) | December 19, 2018
A new set of appropriate use criteria (AUC) released Dec. 17 by a group of cardiovascular professional societies...
Lithotripsy Safe and Effective in Calcified Stenotic Peripheral Arteries
News | Peripheral Artery Disease (PAD) | December 04, 2018
New results from the DISRUPT PAD II study showed no perforations, embolization, reflow or abrupt closures with the...
Lutonix 014 Drug-Coated Balloon Safe and Effective Below the Knee
News | Peripheral Artery Disease (PAD) | November 07, 2018
The Lutonix Drug-Coated Balloon (DCB) showed statistically significant safety equivalence with a standard percutaneous...
Overlay Init