Coronary Angioplasty and Drug-Eluting Stents - Applications of Biotechnology in Cardiovascular Therapeutics - page 284

Table 9.3 (continued)

Company Product Status

Estacure Inc/MediVas 17-b-Estradiol drug-eluting stent Phase II

Guidant Corporation XIENCE ™ V, an everolimus-eluting

stent bought from Biosensor's
International combined with
Guidant's cobalt chromium
MULTI-LINK VISION ®
Coronary Stent System

Phase III

Implant Sciences
Corporation

Stent is fully encapsulated with a
drug-eluting microporous polymer
sheath, which can be impregnated
drugs such as rapamycin or heparin.

Preclinical

Medinol Ltd/ARIAD Stent to deliver ARIAD's mTOR inhibitor,

AP23573, to prevent reblockage of
injured vessels following stent-assisted
angioplasty

In development

Medtronic Vascular Endeavor RESOLUTE zotarolimus-eluting

stent system using new biocompatible
polymer − BioLinx

CE approval in EU,
clinical trials
in USA

MIV Therapeutics Inc DES with hydroxyapatite nanofilm coating

technology

Clinical trial 2007

REVA Medical Inc Nitinol Resorbable stent with

controlled rate and distribution
of drug release. Stent resorbs
once the artery has healed

In development

Sorin Biomedica
Cardio SpA

JUPITER trial using Janus Carbostent
based on Carbofilm ™ technology
and eluting tacrolismus

Phase II

Terumo corporation Nobori ™ uses Biolimus A9 ™

(an analog of sirolimus), is CE
approved for marketing in Europe

NOBORI CORE trials

Custom I
completed
Custom II & III are
ongoing

XTENT Inc Custom NX ® DES Systems: proprietary

stent technology and drug coating,
consisting of variable length stents to
treat diseased coronary artery lesions

© Jain PharmaBiotech

Clinical Trials of Drug-Eluting Stents

Measurements Used in Clinical Trials of DES

The safety, efficacy, and performance of drug eluting stents are assessed using cer-
tain measurements. Data collected at the time of stent implantation is compared
with data collected when a patient is reassessed at follow-up. The time periods for
follow-up are usually 6-9 months in pivotal clinical trials for marketing approval in
the European Union for CE Mark, and 9 months for clinical trials under an IDE
application in the USA conducted to support FDA approval of a PMA application.