Technology | February 19, 2009

Bard Receives FDA Approval for the LifeStent Peripheral Stent

February 19, 2009 - C. R. Bard Inc. this week said it received pre-market approval (PMA) from the FDA to market the LifeStent FlexStar and FlexStar XL Vascular Stent Systems, which are approved for the treatment of occlusive disease in native superficial femoral arteries (SFA) and proximal popliteal arteries.

Two-year clinical data on the LifeStent vascular stent demonstrated a freedom from target lesion revascularization rate of 78 percent vs. 42 percent (p<.0001 for="" percutaneous="" transluminal="" angioplasty="" alone.="" in="" addition="" the="" device="" exhibited="" a="" low="" fracture="" rate="" of="" percent="" at="" months.="">

“The long-term data recently presented are important because they demonstrate the sustained performance of the LifeStent vascular stent,” said Dr. Barry Katzen, M.D., founder and medical director of Baptist Cardiac and Vascular Institute and co-principal investigator of the LifeStent RESILIENT trial. “Of particular significance to clinicians and patients is the approval of the 170 mm stent, the longest commercially available in the U.S. Henceforth, long and diffuse lesions presenting in the SFA can be effectively treated with a single stent, which should help improve both clinical outcomes and procedural costs.”

Bard said approval of the LifeStent positions it as the only company offering a stent indicated for the treatment of SFA and proximal popliteal disease in the U.S.

For more information: www.crbard.com

Related Content

radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
microtubules, heartbeat mechanics, Perelman School of Medicine study

Microtubules in a cardiomyocyte at rest (top) and when compressed. Image courtesy of the lab of Ben Prosser, Ph.D., Perelman School of Medicine, University of Pennsylvania

News | EP Lab| April 29, 2016
Using new high-resolution microscopy, researchers have found that molecular struts called microtubules (MT) interact...
breast cancer, herceptin chemotherapy drug, heart damage, monitoring, Journal of Clinical Oncology study
News | Cardiac Diagnostics| April 28, 2016
April 28, 2016 — Breast cancer patients undergoing treatment with trastuzumab-containing regimens should be monitored
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
coronary CT angiography, CCTA, SCOT-HEART trial substudy, SCCT
News | Computed Tomography (CT)| April 26, 2016
The results of a secondary analysis of the SCOT-HEART trial show that coronary computed tomography angiography (CCTA)...
sleep patterns, metabolic syndrome, risk factors, ACC study
News | Cardiac Diagnostics| April 26, 2016
Taking long naps or being excessively tired during the day is associated with a higher risk for developing metabolic...
CABG, bypass surgery, heart failure, NHLBI study
News | Cardiovascular Surgery| April 25, 2016
Scientists have found that a greater number of patients with coronary artery disease may benefit from coronary artery...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
statins, heart disease, HOPE-3 trial, intermediate-risk patients, hypertension, ACC.16
News | Pharmaceuticals| April 20, 2016
Lowering cholesterol with statins significantly reduced adverse cardiovascular events in people with average...
Stepathlon, exercise, cardiovascular health, Anand Ganesan, ACC.16
News | Patient Engagement| April 20, 2016
April 20, 2016 — A competition that used technology to encourage and track physical activity was effective at...
Overlay Init