Healthcare Industry News: bioresorbable stent
News Release - October 30, 2013
REVA Announces Transmission of ReZolve2 Implant and Pilot Trial Update at TCT 2013SAN DIEGO, Oct. 30, 2013 -- (Healthcare Sales & Marketing Network) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announces that in conjunction with Transcatheter Cardiovascular Therapeutics 2013 ("TCT"), which is being held this week in San Francisco, a patient implant with the ReZolve(R)2 bioresorbable scaffold was transmitted live via satellite from the Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil to an audience in the Main Arena. The implant was performed by Dr. Alexandre Abizaid, Director of Invasive Cardiology, and study co-investigator, Dr. J. Ribamar Costa.
The scaffold was implanted in a patient that presented with a blockage of the left anterior descending artery of the heart. The lesion was approximately 80% blocked and had evidence of moderate calcium. The procedure was performed using a 6 French radial approach, in which the scaffold is delivered to the heart through the radial artery of the wrist.
Commenting on the case, Dr. Abizaid stated, "We achieved a very successful acute result from this implant. The scaffold was easily delivered, and the procedure was aided by the complete visibility of the scaffold under x-ray and the ability to achieve the desired implant diameter with a single inflation."
"This case marks the 87th patient enrolled in our ReZolve2 clinical trial," commented REVA's CEO, Bob Stockman. "The follow-up data from this case, along with data from up to 125 patients enrolled in the trial, will be used to apply for European CE Mark of the product toward the end of 2014."
Additionally, Dr. Ricardo Costa, also from the Institute Dante Pazzanese of Cardiology, presented 12-month data at TCT on patients who were enrolled in the RESTORE pilot clinical trial between December 2011 and July 2012. The RESTORE pilot clinical trial was designed to evaluate the safety and performance of the first generation ReZolve(R) sirolimus-eluting bioresorbable coronary scaffold. Twelve-month angiographic follow-up was conducted to evaluate the change in the lumen area between the time of treatment when blood flow was restored and the time of follow-up, referred to as late lumen loss ("late loss"). Permanent drug-eluting stents have historically exhibited late loss values of 0.20 mm to 0.40 mm, which have generally corresponded to positive long-term outcomes.
In the patients treated with ReZolve who remained event free after treatment, imaging results demonstrated a mean in-stent late loss of 0.29 mm, which is well within the range of safety and performance of drug-eluting metal stents and bioresorbable scaffolds that are used today. When imaging results for patients who had undergone retreatment for focal in-stent restenosis, or renarrowing of the artery at the implant site are taken into consideration, the mean in-stent late loss is 0.69 mm.
Commenting on the results, Dr. Costa stated, "The positive late loss results seen in the majority of patients demonstrates the platform's ability to successfully treat coronary artery disease, before resorbing from the body, and returning the patient's artery to its natural function. To reduce the incidence of retreatment, REVA developed ReZolve2, which is a lower profile scaffold with an approximate 30% increase in radial strength when compared to the original ReZolve device. Our center is now enrolling patients in a larger clinical trial with ReZolve2, and positive 30-day data was presented on the first 65 patients at TCT earlier this week."
"The data from the patients treated with our first generation scaffold has been instrumental in advancing our product platform," commented REVA's CEO, Bob Stockman. "The current performance of ReZolve2, along with the additional advantages that will be realized by REVA's pipeline bioresorbable scaffolds that are now in development, position REVA very strongly for the future."
The presentation materials delivered by Dr. Costa at the conference are posted under the Investor Relations section of REVA's website at www.revamedical.com.
REVA is a development stage medical device company incorporated in Delaware, USA, that is focused on the development and eventual commercialization of its proprietary bioresorbable stent products. The ReZolve(R) product family, which is in a clinical study phase, combines REVA's proprietary stent design with a proprietary polymer that is metabolized and cleared from the body. REVA's anticipated initial commercial product, the ReZolve2 scaffold, is designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. In addition, by early encapsulation of the stent in the artery tissue coupled with the loss of scaffold structure over time, the ReZolve2 scaffold may reduce the incidence of late forming blood clots or otherwise reduce long-term disease progression, potential benefits of bioresorbable scaffolds that have yet to be proven. REVA will require clinical results and regulatory approval before it can begin selling the ReZolve2 scaffold.
This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that are not statements of historical fact, including those statements that address future operating performance and events or developments that we expect or anticipate will occur in the future, are forward-looking statements, such as those statements regarding our ability to obtain the regulatory approvals required to market our ReZolve(R) scaffold, our ability to timely and successfully complete our clinical trials, our ability to protect our intellectual property position, our ability to commercialize our products if and when approved, our ability to develop and commercialize new products, and our estimates regarding our capital requirements and financial performance, including profitability. You should not place undue reliance on these forward-looking statements. Although management believes these forward-looking statements are reasonable as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to vary materially 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 United States Securities and Exchange Commission (the "SEC") on February 29, 2013. Any forward-looking statements in this announcement speak only as of the date when made. REVA does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Source: REVA Medical
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