Stents biodivysio

The one-month farm swine studies evaluated safety following implantation of two doses of batimastat loaded on the 18 mm BiodivYsio stent in comparison to control stent without batimastat. Two batimastat doses were evaluated as described in Table 2. No deaths occurred during the implantation procedure and no sub-acute death or stent thrombosis was observed during the follow-up period. Histological examination confirmed that all the vessels were patent, without the presence of thrombus in the vessel lumen, All sections showed stent struts to be completely covered, leading to a smooth endoluminal surface. There was no excessive inflammatory response at stent struts in BiodivYsio-Batimastat-treated sections compared with the control sections. Medial and adventitial layers appeared similar in all three groups. The perivascular nerve fibers, the adipose tissue, and adjacent myocardium appeared normal in control and Biod/VV s/o-Batimastat-treated sections. Therefore, these studies demonstrated that the Biod/VY s/o Batimastat stent at CTD and >CTD was well tolerated up to 28 days. 

The long-term (three months) safety study was carried out on Yucatan mini-pigs using two doses of batimastat loaded on the 15 mm BiodivYsio stent in comparison to a control stent without batimastat, as outlined in Table 2. The evaluation criteria included vessel lumen area, neointimal thickness and area, absence/presence of thrombus, angiographic percent stenosis, and lumen loss. The QCAand histological analysis at three months follow-up are presented in Table 3. 

PTCA). The primary objective was to evaluate the occurrence of major adverse cardiac events (MACE) [death, recurrent myocardial infarction (Ml), or clinically driven target lesion revascularization] 30 days postprocedure. The secondary objectives were to evaluate the binary restenosis, incidence of (sub)acute stent thrombosis at 30 days follow-up, MACE at 6 and 12 months and the QCA endpoints at 6 months. This study was designed to allow a comparison with the patient population and the results of a larger randomized DISTINCT (BiodivYsio stent in controlled clinical trial) study previously conducted in the U.S. 

Purpose To evaluate the acute safety and effectiveness of the BiodivYsio Batimastat stent compared to the standard BiodivYsio stent... 

This study was set up to allow a comparison of the patient population and the results with the larger randomized DISTINCT study previously conducted in the U.S.A. The Biod/VV s/o Batimastat OC Stent showed no improvement in the overall unadjudicated MACE (18%) and restenosis (23%) rate at six months when compared to the nondrug-coated BiodivYsio stent used in the DISTINCT study, where the reported adjudicated MACE and restenosis rate were 17% and 19,7%, respectively. This six-month follow-up data suggest that the Biod/VYs/o Batimastat OC Stent did not offer the additional benefit over the standard BiodivYsio stent (Table 7),... 

Later studies from Japan showed beneficial effect of antioxidants-releasing BiodivYsio stent. Carvedilole and prombucole were induced in porcine coronary arteries. 

Carvedilol-releasing BiodivYsio stents minimized the hyperplasia by 42% and maximized the lumen area by 20% compared with simple BiodivYsio stents. No positive effect was observed in the Probucole group (52). 

Galli et al. (63,64) demonstrated that primary stenting of AMI with PC-coated stent leads to excellent short- and midterm clinical outcomes and a low restenosis, despite a reduced heparin therapy. As in other studies, the reported restenosis rate using the BiodivYsio stent in the small vessels is lower than that using any other metallic stents (46,47, 49,64-68). 

The first human experience with a 17(3-estradiol-eluting stent was recently published (35). The Estrogen and Stents to Eliminate Restenosis (EASTER) trial was a single-center feasibility study testing l7(3-estradiol-eluting BiodivYsio stents in 30 patients with de novo coronary lesions. The purpose of the EASTER study was to evaluate the feasibility of 17(3-estra-diol-eluting stents to inhibit restenosis in humans. 

BiodivYsio stents without estradiol (Figs, 7 and 8), Only 3,3% (I of 30) patients required TVR. In addition, there was minimal in-segment late-loss and no edge restenosis, These early results may reflect an improved vessel healing after stenting, which would be clinically very desirable. 

Boland, J.L., Cotbeij, H.A., Van Der Giessen, W., et til. Multicenter evaluation of the phos-phorylcholine-coated biodivYsio stent in short de novo coronary lesions The SOPHOS study. Int. J. Cardiovasc. Interv. 3, 215-225 (2000). doi 10.1080/14628840050515966... 

Kim (128) 2005 BiodivYsio PC Pig coronary art Carvedilol Probucol 7 ng/stent 52 ng/stent Coated Yes No... 

Kwok (150) 2005 BiodivYsio PC Human coronary art Angiopeptin 22 jxg 126 ng/stent — —... 

I 19 Huang Y Liu X, Wang L, et al. Local methylprednisolone delivery using a BiodivYsio phosphorylcholine-coated drug-delivery stent reduces inflammation and neointimal hyperplasia in a porcine coronary stent model, Int J Cardiovasc Intervent 2003 5(3) I 66-171. 

Liu X, Huang Y Hanet C, et al. Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE) a first-in-human multicenter pilot trial. Catheter Cardiovasc Interv 2003 60(2) 172-178. 

Scanning electron micrograph showing continuous endothelial cell coverage of the stent struts after five-day implantation (preclinical study of clinical trial dose BiodivYsio Batimastat Stent). 

Abbreviations-. AS. added support BRILLIANT-EU. batimastat (BB94) anti-restenosis trial utilizing the BiodivYsio local drug delivery FC-stent CTD. clinical trial dose OC, open cell. 

Clinical studies with the biodivysio batimastat stent... 

One clinical registry has been performed to evaluate the safety of the BiodivYsio Batimastat stent in countries outside the U. S. 

One hundred and seventy-three patients (134 males and 39 females), symptomatic patients with stable angina pectoris (Canadian Cardiovascular Society I, 2, 3, or 4) or unstable angina pectoris with documented ischaemia (Braunwald Class IB-C, IIB-C, or IIIB-C) or documented ischemia with a single de novo lesion in a coronary artery suitable for treatment with a single BiodivYsio DD OC-coated coronary stent preloaded with Batimastat of I 1, 15, 18, 22, or 28 mm length by 3.0, 3.5, or4.0-mm diameter were included in the study, providing they met the selection criteria. 

All patients were required to agree to a six-month clinical and angiographic follow-up and had to be over 18 years old, The reference vessel diameter (R.VD) of the treated lesion was visually estimated >2.75 and <3.5 mm in diameter, target lesion stenosis >50% and < 100%. Noncaldfied lesions, de novo lesions within a native coronary artery, <25 mm long, requiring one appropriately sized BiodivYsio Batimastat OC stent were included. 

BATMAN BATiMastat(BB94) Anti-restenosis trial utilizing the BiodivYsio local drug delivery PC-steNt ... 

Purpose To evaluate safety and efficacy of the BiodivYsio Batimastat SV stent versus balloon angioplasty in small coronary arteries... 

Batimastat(BB94)anti-Restenosis trlaL utiLizIng the BiodivYsio locAl drug Delivery PC-steNT ... 

In addition to the preclinical studies, the clinical studies demonstrate that stent-based delivery of batimastat in coronary artery using the Biod/VYs/o DD stents is a feasible and safe procedure. Results from the BRILLIANT study however did not show a positive effect of the BiodivYsio Batimastat OC stent on TLR, late loss, and binary restenosis. 

Bakhai A, Booth J, Delahunty N, et al. The SV stent study a prospective, multicentre, angiographic evaluation of the BiodivYsio phosphorylcholine coated small vessel stent in small coronary vessels. IntJ Cardiol 2005 102 95-102. 

Galli M, Bartorelli A, Bedogni F et al. Italian BiodivYsio open registry (BiodivYsio PC-coated stent) study of clinical outcomes of the implant of a PC-coated coronary stent. J Invasive Cardiol 2000 12 452-458. 

Shinozaki N, dbkoi H, Iwabuchi M, et al. Initial and follow-up results of the BiodivYsio phosphorylcholine coated stent for treatment of coronary artery disease. Circ J 2005 69 295-300. 

Beaudry Y Sze S, Fagih B, Constance C, Kwee R. Six-month results of small vessel stenting (2.0-2.8 mm) with the Biodivysio SV stent. J Invasive Cardiol 2001 13 628-63 I. 

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