CR Bard Resilient trial results showed the Bard LifeStent Vascular Stent improved patency and reduced revascularization rates in patients with moderate-length lesions in the superficial femoral artery (SFA) and proximal popliteal artery compared to patients treated with percutaneous transluminal angioplasty (PTA).
CR Bard claimed that the LifeStent Vascular Stent is the only stent approved by the FDA and commercially available for use in the SFA and proximal popliteal artery, both of which are above the knee.
CR Bard said that the patients treated with the LifeStent Vascular Stent were more than two times as likely to maintain primary patency compared to PTA patients at six months and 12 months post procedure.
Additionally, there was no difference between the major adverse clinical events (MACE) rates for the treatment groups. Freedom from MACE at six months for the stent group was 93.1% and for the angioplasty group was 92.8%. At 12 months, freedom from MACE was 85.8% for the stent group and 86.6% for the angioplasty group.
Barry Katzen, founder and medical director of Baptist Cardiac & Vascular Institute, said: “The Resilient trial shows that the LifeStent Vascular Stent is a safe device both in terms of major adverse clinical events as well as stent fracture rates.”
John Laird, medical director, University of California, Davis, Vascular Center, and co-principal investigator for the Resilient trial, Said: “This trial provides compelling evidence that the self-expanding nitinol stent can keep the arteries open and reduce the need for additional procedures better than balloon angioplasty alone. The data suggest this stent will improve the outcomes clinicians can expect when treating lesions in the SFA and proximal popliteal artery.”
Headquartered in Murray Hill, CR Bard is a multinational developer, manufacturer and marketer of life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.