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:

Related Content

UAB, University of Alabama at Birmingham study, stroke prevention, non-valvular atrial fibrillation, NVAF
News | Atrial Fibrillation| October 25, 2016
A recent study from University of Alabama at Birmingham (UAB) researchers published in PLOS ONE compares different...
pediatric echocardiograms, cardiovascular ultrasound, therapy dog impact, animal-assisted therapy, Human Animal Bond Research Initiative, HABRI
News | Cardiovascular Ultrasound| October 25, 2016
The Human Animal Bond Research Initiative (HABRI) announced it has awarded a $44,000 grant to Duke University School of...
St. Jude Medical, ADO II AS trial, congenital heart disease, PDA, Amplatzer Duct Occluder II AS
News | Congenital Heart| October 19, 2016
St. Jude Medical Inc. announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric...
Lantheus, flurpiridaz F-18, myocardial perfusion imaging, MPI, cardiac stress testing, ASNC 2016
News | Radiopharmaceuticals and Tracers| October 17, 2016
Lantheus Holdings Inc. announced in late September that sub-analysis data from the first Phase 3 study of flurpiridaz F...
Medtronic, FIRE AND ICE trial, Arctic Front, cryoballoon catheter ablation, radiofrequency RF ablation, study results, Asia Pacific Heart Rhythm Society Scientific Sessions
News | Ablation Systems| October 17, 2016
Medtronic plc last week unveiled new health economic analysis data from the FIRE AND ICE trial that favor cryoballoon...
transcarotid artery revascularization, TCAR Surveillance Project, Society for Vascular Surgery Patient Safety Organization, SVS PSO,
News | Stents Carotid| October 13, 2016
A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in...
Shockwave lithoplasty system, VIVA 16, Vascular Interventioanl Advances, VIA Physicians, late-breaking endovascular clinical trial results
News | Cath Lab| October 12, 2016
VIVA (Vascular Interventional Advances) Physicians announced a number of highly anticipated late-breaking clinical...
ZipLine Medical, Zip Surgical Skin Closure, cath lab time savings, PACE study
News | EP Lab| October 10, 2016
October 10, 2016 — ZipLine Medical Inc.
Mercator MedSystems, Bullfrog Micro-Infusion Device, DANCE trial, VIVA 2016, 13-month results
News | Peripheral Arterial Disease (PAD)| October 07, 2016
Mercator MedSystems recently announced that 13-month data from the DANCE trial was presented during a late-breaking...
Keystone Heart, TriGuard Embolic Protection Device, Neuro-TAVR study, brain lesions, American Journal of Cardiology
News | Heart Valve Technology| October 03, 2016
Keystone Heart Ltd. announced data recently published in the American Journal of Cardiology demonstrating new brain...
Overlay Init