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Market watch
nary anatomies. According to a
Product News
Abbott announces CE mark for world’s longest coronary drug- eluting stent Abbott has announced CE mark in Europe for the Xience Xpedition 48 everolimus-eluting Coro- nary stent system. Xience Xpedition 48, according to a company release, is available in 48mm which is currently the longest stent.
Studies have indicated, that physicians chose to use multiple shorter length stents to meet the challenges of treating long or lesions in up to 30% of interventional heart procedures, as conven- tional stent sizes may not always fully cover the lesion. It has been shown, however, that the use of a single stent instead of multiple stents may result in several procedural benefits, including the use of fewer devices, less ex- posure to X-ray during the procedure, and reduced procedure time—which could lead to economic benefits. “With global economic pressures impacting hospitals and healthcare systems around the world, products like Xience Xpedition 48 may provide important cost savings to the system,” said Peter Smits, Maasstad Zieken- huis, Rotterdam, The Netherlands. “I believe that this new treatment option, backed by the ro- bust clinical outcomes of the Xience family of drug -eluting stents, will help physicians in the treat- ment of long lesions.” According to the com-
pany, the Xience Xpedi- tion 48 is supported by strong clinical evidence from the Xience family of drug-eluting stents, including data from more than 53,000 patients across more than 100 studies with long-term outcomes up to five years. The safety of the Xience family of drug-eluting stents has been demon- strated in a number of clinical trials, according to Abbott, representative of routine clinical practice.
Xience Xpedition is available in diameters ranging from 2.25mm to 4mm, including a 3.25mm diameter, and lengths ranging from 8mm to 48mm.
Biosensors
receives CE mark approval for BioMatrix NeoFlex BioMatrix NeoFlex, according to the com- pany, has received the CE mark and features a new advanced stent delivery system to improve push- ability, trackability and crossability. It also has a lower lesion entry profile than its predecessor. Bio- Matrix NeoFlex retains the same combination of abluminal biodegradable polymer coating, propri- etary limus drug biolimus A9 (BA9).
Results from the final five-year LEADERS data, presented at TCT 2012, demonstrated that BioMatrix Flex signifi- cantly reduced the risk of clinical events in the very late phase, and showed a significant reduction in very late stent thrombosis (VLST) compared with Cypher Select.
“CE mark approval for BioMatrix NeoFlex rep- resents another important step forward for the Bio- Matrix brand, improving our flagship product yet further with enhanced de- liverability ”, commented Jeffrey B Jump, president of Biosensors’ Cardio- vascular Division. “Since the launch of the original BioMatrix in 2008, we have been the driving force in biodegradable polymer stent technology. BioMatrix NeoFlex will enable us to retain this position.”
BioMatrix NeoFlex will be rolled out in all CE mark global markets over the coming months.
CE mark for longer lengths of Cre8
After receiving the CE mark for longer lengths of its polymer- free, drug-eluting stent, Cre8 [right], CID is now provide able to provide
the stent in diameters from 2.5mm to 4.5mm and lengths from 8mm to 38mm.
According to a press release, the Cre8 polymer- free, drug-eluting stent embodies the most ad- vanced stent technologies to treat coronary vascular disease. Its unique distinc- tive features—abluminal reservoir technology, amphilimus formulation and bioinducer surface— make Cre8 the only very effective polymer-free drug-eluting stent avail- able.
The press release re- ported that the proprietary abluminal reservoir tech- nology provides a consist- ent drug loading onto the stent platform, thus enabling a controlled and directed elution exclu- sively targeted to the ves- sel wall. The innovative amphilimus formulation, which is sirolimus plus an organic acid, is the first known use of a carrier to enhance drug bioavail- ability and drug distribu- tion to the entire vessel wall. The bio inducer surface, a second genera- tion integral pure carbon coating, demonstrates excellent results in terms of stent endothelialisation and struts coverage. The NEXT randomised study showed that Cre8 was superior to the Taxus Liberté (Boston Scientif- ic) stent, improving drug- eluting stent performance specifically in complex patients such as diabetics who usually present long coronary lesions.
FDA clears Cordis’s Adroit guiding catheter Cordis has announced that the FDA has cleared its Adroit 6F guiding catheter for use in various coro-
company press release, the catheter’s innova- tive hybrid braid wire technology not only enables the production of a guide catheter with the largest lumen size on the US market, it also facilitates better control and back up support. In addition, the new innova- tive design incorporating a flexible distal segment and soft longer tip allows atraumatic placement and stability.
Celine Martin, world- wide president, Cordis, said: “The new Adroit guiding catheter, allows physicians to have more options for treating a wide range of challeng- ing cases. It accommo- dates easier advance- ment of devices with its 0.072” diameter while providing better sup- port and control at the same time. These fea- tures enhance treatment options for physicians, including the treatment of cases with complex lesions and those to be conducted using the radial approach.”
FDA approves trial of Desyne Nx novolimus- eluting stent The FDA has given Elixir Medical the go ahead to start patient enrolment for its investigational device exemption (IDE) EXCELLA III clinical trial, which will be used to support pre- market approval of the company’s Desyne Nx novolimus-eluting stent system.
The Desyne Nx stent elutes a low dose of Elixir’s proprietary drug novolimus, an active metabolite of sirolimus, via an ultrathin durable coating. The EXCELLA III clinical trial will be a prospective, controlled, multicentre, single- blind study com- paring Desyne Nx with the Resolute zotarolimus-
eluting stent sysem (Medtronic) as control in a 2:1 randomisa- tion of 2,051 patients recruited from USA and international centres. The principal investigator for the
EXCELLA III study is Martin B Leon, New York Presbyterian Hospital/Co- lumbia University Medi- cal Center, New York, USA.
The primary endpoint of the EXCELLA III trial is target lesion failure, a composite measure of safety and effectiveness at 12 months defined as cardiac death, myocar- dial infarction related to the target vessel, and clinically-indicated target lesion revascularisation. In addition, a subset of patients will be evaluated
August 2013
in Washington, DC, USA. The Desyne stent demon- strated both non-inferior- ity and superiority to the Zotarolimus-eluting con- trol stent for the primary endpoint of in-stent late lumen loss and achieved low clinical event rate through three years. The data collected from the global use of Desyne will be used to supplement the future pre-market ap- proval application in the USA for the Desyne Nx novolimus stent system.
Adroit
for angiographic end- points, and all patients will be followed for five years.
“EXCELLA III will be a promising trial building upon the ex- cellent and sustained clinical outcomes of the EXCELLA II trial,” said Leon. “I am excited about Desyne
Nx’s potential to validate the safety and long-term performance in this large clinical trial.”
According to a compa- ny press release, the IDE approval for the EXCEL- LA III trial in the USA follows the successful international commercial launch of Desyne, which gained CE mark approval based on the results of the EXCELLA II trial. The trial was a randomised controlled study that enrolled 210 patients at 22 clinical centres in Europe, Australia, New Zealand, and Brazil. The three-year follow-up results were presented last October at the Transcatheter Thera- peutics (TCT) Conference
CE mark for Combo dual therapy stent OrbusNeich has an- nounced that it has received the CE mark for its dual therapy coronary stent (Combo), and that it has launched the device in Europe and mar- kets in Asia Pacific and Middle East Regions. According to a com- pany press release, the Combo dual therapy stent is the first stent to both accelerate endothe- lial coverage and control neo-intimal proliferation through the combination of OrbusNeich’s pro- healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.
Roxana Mehran, Mount Sinai Medical Center, USA, said, “I believe that Combo is the next generation drug-eluting stent, combining the anti-restenotic property of drug-eluting stents with endothelial progenitor cell capture, which is able to heal the surface of the stent. We are most excited about the possibility of actually having a stent for which you do not need prolonged dual antiplate- let therapy (DAPT), and I think that is the future. Obligatory, prolonged DAPT is no longer going to be the standard— we cannot accept that anymore. And so, we are looking for a safer stent, and I think this very unique and interesting platform has incredible promise.”
Nine-month clini- cal outcomes from the REMEDEE study con-
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