爱华网博主：全降解支架在实现传统金属支架有效性的同时还能帮助患者血管功能恢复正常，而这是传统金属支架所无法达到的。雅培的ABSORB系列临床试验结果越来越坚定了全降解支架是冠脉介入治疗的第4次革命（I，CABG到PTCA；II，PTCA到裸金属支架；III，裸金属支架到药物洗脱支架），而继ABBOTT的ABSORB和Elixir的DESolve获得CE后，REVA全降解支架也获得越来越多的期待，相对比前两种全降解支架，REVA因其含碘所以支架本身具有X射线可视性（ABSORB需要在支架两端载有金属片用以显影），此外REVA支架特有的扣式设计帮助其相对比前两种支架拥有更具选择性的打开尺寸（ABSORB由于材料及工艺所限，目前还无法覆盖所有金属支架尺寸范围）。无论哪种全降解支架能够引领风骚，我们都希望随着技术的进步能够更好的改善病人的生活质量。
At the Paris Course on Revascularization ("EuroPCR") being heldthis week in Paris, France, REVA Medical, Inc. (ASX:RVA) ("REVA" orthe "Company") released 12-month data on a subset of patientsenrolled in the RESTORE clinical trial. The RESTORE trial isevaluating the safety and performance of the first-generationReZolve® sirolimus-eluting bioresorbable coronaryscaffold, which was implanted in 22 patients between December 2011and July 2012.
In an analysis of patients that completed 12-month angiographicfollow-up to-date (8 of 22), imaging results demonstrated a meanin-stent late lumen loss ("late loss") of 0.20 mm. A finding of0.20 mm means there was very little change in the lumen areabetween the time of treatment when blood flow was restored and thetime of follow-up. Permanent drug-eluting stents have historicallyexhibited late loss values in the range of 0.20 mm to 0.40 mm,which has generally corresponded to positive long-termoutcomes.
Commenting on the results, principal investigator Dr. AlexandreAbizaid, Director of Invasive Cardiology at the Instituto DantePazzanese de Cardiologia in Sao Paulo, Brazil, stated, "The12-month late loss demonstrated to-date with the ReZolve scaffoldis well within the range of safety and performance of drug-elutingmetal stents and bioresorbable scaffolds that are used today. Thispreliminary analysis is very encouraging as it indicates that theReZolve scaffold has the potential to successfully treat coronaryartery disease, with the added benefit of resorbing from the bodyover time, allowing the artery to return to its naturalfunction."
Since REVA's most recent report of clinical data, which includedan analysis of all patients through a six-month follow-up, twoadditional patients were retreated for focal in-stent restenosis,or renarrowing of the artery at the implant site, and an additionalpatient died from unknown causes. "We learned a great deal fromthis initial trial," commented REVA's Chairman and CEO, BobStockman. "The low late lumen loss is a very positive indication ofthe effectiveness of the ReZolve product platform, and we remainvery encouraged by this result. The adverse clinical eventsrelating to restenosis occurred in patients that were enrolled inthe early stages of the study; the learning from these early casesled to improved lesion preparation techniques for optimalbioresorbable scaffold placement, as well as design enhancements inREVA's commercial product, ReZolve2, which began clinicalenrollment earlier this year."
ReZolve2 is a lower profile and sheathless version of thefirst-generation ReZolve scaffold that offers significantlyimproved deliverability and an approximate 30% increase in scaffoldstrength to provide increased support to significant coronaryartery lesions before being resorbed by the body. REVA beganimplanting ReZolve2 in patients in March 2013. The initial threeclinical sites enrolled eight patients during the first month ofthe study; enrollment with ReZolve2 will expand to approximately 30clinical centers, including additional sites in Australia, Germany,and New Zealand. REVA expects to enroll 125 patients with ReZolve2by September of this year to provide the data needed to apply forEuropean CE Marking, which will allow for commercial sales inEurope and other countries that recognize the mark.
Physicians have been pleased with the improved deliverability ofReZolve2 and have successfully implanted the scaffold using boththe traditional femoral and the increasingly common radialapproach, which delivers the scaffold through an artery in thearm.
Prof. Dr. med. Norbert Frey, Chief of the Department ofCardiology at the University of Kiel in Germany, was the firstphysician in Germany to implant the ReZolve2 scaffold. "We havebeen pleased with the procedural outcomes in our first cases usingthe ReZolve2 scaffold. The improved deliverability has allowed usto expand the number of patients that are eligible to participatein the study and we look forward to enrolling additional patientswith this newest bioresorbable scaffold."
At EuroPCR, REVA presented a scientific poster, REVA RESTORETrial: Interim 12-Month Clinical Results of the ReZolveBioresorbable Scaffold and ReZolve2 Clinical Program Update, whichprovided additional details regarding REVA's clinical trial resultsto date. A copy of the poster is available on REVA's website atwww.revamedical.com.
About REVA
REVA is a development stage medical device company incorporatedin Delaware, USA, that is focused on the development and eventualcommercialization of its proprietary bioresorbable stent products.The ReZolve® product family, which is in a clinicalstudy phase, combines REVA's proprietary stent design with aproprietary polymer that is metabolized and cleared from the body.REVA's anticipated commercial product, the ReZolve2 scaffold, isdesigned to offer full x-ray visibility, clinically relevantsizing, and a controlled and safe resorption rate. In addition, byearly encapsulation of the stent in the artery tissue coupled withthe loss of scaffold structure over time, the ReZolve2 scaffold mayreduce the incidence of late forming blood clots or otherwisereduce long-term disease progression, potential benefits ofbioresorbable scaffolds that have yet to be proven. REVA willrequire clinical results and regulatory approval before it canbegin selling the ReZolve2 scaffold.
Forward-Looking Statements
This announcement contains or may contain forward-lookingstatements that are based on management's beliefs, assumptions andexpectations and on information currently available to management.All statements that are not statements of historical fact,including those statements that address future operatingperformance and events or developments that we expect or anticipatewill occur in the future, are forward-looking statements, such asthose statements regarding our ability to obtain the regulatoryapprovals required to market our ReZolve®scaffold, our ability to timely and successfully complete ourclinical trials, our ability to protect our intellectual propertyposition, our ability to commercialize our products if and whenapproved, our ability to develop and commercialize new products,and our estimates regarding our capital requirements and financialperformance, including profitability. You should not place unduereliance on these forward-looking statements. Although managementbelieves these forward-looking statements are reasonable as andwhen made, forward-looking statements are subject to a number ofrisks and uncertainties that may cause our actual results to varymaterially from those expressed in the forward-looking statements,which risks and uncertainties are described in the "Risk Factors"section of our Annual Report on Form 10-K filed with the UnitedStates Securities and Exchange Commission (the "SEC") on February27, 2013. Any forward-looking statements in this announcement speakonly as of the date when made. REVA does not assume any obligationto publicly update or revise any forward-looking statements,whether as a result of new information, future events, orotherwise.
