Noticias

Noticias

  • Título: Bard Announces First Patient Enrolled in Lutonix In-Stent Restenosis Clinical Trial
  • Fecha: 18-03-2014

  • MURRAYHILL, NJ -- (March 18, 2014) -- C. R. Bard, Inc. (NYSE: BCR) today announcedthe enrollment of the first patient into the Lutonix® In-Stent Restenosis (ISR)Clinical Trial. Dr. Carlos Mena, Medical Director, Vascular Medicine atYale – New Haven Hospital, is the principal investigator of the pivotalmulti-center randomized Investigational Device Exemption (IDE) trial which isexpected to enroll several hundred patients at 30 sites in the U.S.

    The study – the first of its kind in the U.S. – will compare the safety andefficacy of the Lutonix® 035 Drug Coated Balloon PTA Catheter (DCB) to astandard angioplasty balloon (PTA) for the treatment of femoropopliteal arteryin-stent restenosis (SFA-ISR). ISR is a blockage occurring in a stentedvessel and SFA-ISR occurs specifically within the femoropopliteal artery.

    SFA-ISR is a common problem, with 20 to 35 percent restenosis rates at 12months. There are limited treatment options today and the only approved therapyfor SFA-ISR in the U.S. is PTA with a bare, non-drug coated balloon. Restenosisrates for PTA are as high as 65 percent at 12 months, driving the desire for amore durable solution.

    'With today's treatment limitations, in-stent restenosis remains difficultto treat,' said Dr. Mena. 'I am excited to lead this groundbreakingstudy and for the potential to provide the medical community a new tool totreat patients with these complex challenges.'

    Designed to treat atherosclerotic lesions in the SFA and popliteal arteries,the Lutonix® DCB is similar to a standard angioplasty balloon, but is coatedwith a low dose of the anti-proliferative drug, paclitaxel, with excipientssorbitol and polysorbate. The combination forms a high-integrity coatingadhesion intended to be durable enough to 'stick' to the balloonduring prep and transit while also allowing release of the drug to the targetvessel during a 30-second balloon inflation. The coating is designed asadjunct therapy to standard mechanical dilatation of the vessel to restoreblood flow. The Lutonix® DCB is being studied in the SFA in Levant 2, thefirst and largest prospective, multi-center, randomized U.S. IDE Trial.

    Clinical Trial Design
    The Lutonix® ISR clinical trial is a prospective, multicenter, single-blind,randomized, controlled trial to compare the safety and effectiveness of theLutonix® 035 Drug Coated Balloon PTA Catheter (DCB) to a standard angioplastyballoon for the treatment of SFA-ISR. Patients will be randomized (2:1)for treatment with a Lutonix® DCB (study arm), or a standard non-coatedangioplasty balloon (control arm).

    The Lutonix® ISR trial is one of several studies designed to produce long-termclinical evidence of the Lutonix® DCB in order to expand treatment options forperipheral arterial disease. The Lutonix® DCB is not commerciallyavailable in the U.S. and is limited to investigational use under anInvestigational Device Exemption (IDE). Lutonix® has submitted to FDA theresults from the LEVANT 2 clinical trial and is currently seeking approval ofthe Lutonix® DCB in the U.S. The Lutonix® DCB is commercially availablein Europe.

    C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, NJ, is aleading multinational developer, manufacturer and marketer of innovative,life-enhancing medical technologies in the fields of vascular, urology,oncology and surgical specialty products.




  • Fuente: endovascular.es