|By PR Newswire||
|March 5, 2014 12:21 PM EST||
DURHAM, N.C., March 5, 2014 /PRNewswire/ --- Micell Technologies, Inc. today announced that the long-term clinical outcomes from the DESSOLVE I and II clinical trials recently were presented at the Cardiovascular Research Technologies (CRT) Conference held in Washington, D.C., February 22 – 25. The data presentation, "MiStent SES Clinical Program: DESSOLVE I and II Trials 2-Year Follow-up" was delivered by Alexandra Lansky, M.D., Director, Interventional Cardiovascular Research and Angiography Core Laboratory Services with the Yale University School of Medicine, New Haven, Conn.
The MiStent SES is a thin-strut drug-eluting stent with a bioabsorbable polymer developed to optimize vessel healing in patients with coronary artery disease. The mechanism of action is a unique drug delivery profile with three times longer drug presence versus absorbable polymer. Following elimination of the polymer in 90 days, the anti-proliferative effects of sirolimus continue to be delivered to the artery for up to nine months. Although several current bioabsorbable DES also report drug delivery for up to nine months or more, the MiStent SES' capability to continue drug delivery in the absence of potential inflammatory-causing polymers is distinctive in this generation of DES with bioabsorbable coatings.
Dr. Lansky commented, "MiStent SES is the only product in its class to optimize local drug delivery properties by providing up to nine months of drug presence with only three months for polymer absorption. The rapid elimination of the polymer with the sustained anti-inflammatory and anti-restenotic drug six months beyond the presence of the polymer was designed to allow normal healing while providing effective suppression of neointimal hyperplasia. Detailed imaging by IVUS, OCT and angiography extending from four to 18 months post-stent implantation confirmed desirable bare-metal stent-like healing."
The DESSOLVE I trial demonstrated minimal progression of late lumen loss between eight and 18 months follow-up, with no target lesion MACE events through two years. The DESSOLVE II randomized trial two-year MACE rate was 6.7% for MiStent and 13.3% for the Endeavor DES control group. There were no probable or definite stent thromboses related to MiStent SES use in either trial through two years. Detailed serial IVUS, angiographic, and OCT imaging through 18 months in DESSOLVE I and angiographic and OCT imaging in conjunction with endothelial function testing in DESSOLVE II demonstrated excellent healing, effective suppression of neointimal hyperplasia with maintenance of normal endothelial function, and a sustained safety profile.
Elazer Edelman, M.D., a Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology at Massachusetts Institute of Technology, Professor of Medicine at Harvard Medical School and Senior Attending Physician in the Coronary Care Unit at the Brigham and Women's Hospital in Boston, and a consultant to Micell added, "MiStent SES provides an exciting new level of consistency and performance for drug-eluting stents. Detailed tissue evaluations in animal studies, extensive imaging studies in both pre-clinical and clinical settings and two-year clinical data from the DESSOLVE clinical trial program correlate with each other to support a normal tissue healing process."
About the MiStent SES
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES is intended to precisely and consistently control drug elution and limit polymer exposure duration, thereby reducing the safety risks associated with current commercially available drug-eluting stent technologies.
The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.
Using an approved drug (sirolimus) and polymer (PLGA), Micell's patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of the Eurocor (CE Marked) Genius® MAGIC Cobalt Chromium Coronary Stent System, a state-of-the-art bare-metal stent, which has demonstrated excellent deliverability, conformability, and flexibility.
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare-metal stent, and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.
Micell was granted CE (Conformité Européenne) Mark approval for MiStent SES for the European Economic Union in June 2013; it is not approved in the United States or any other countries. A two year follow-up of DESSOLVE I and II clinical studies' subjects was completed in 2013, and these patients currently are undergoing long-term follow-up.
About DESSOLVE I and DESSOLVE II Studies
The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the MiStent SES®, treated thirty patients with de novo lesions in coronary arteries ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm length stent. Subjects were enrolled across five study centers in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months and all available patients at 18 months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point.
The DESSOLVE II CE (Conformite Europeenne) Mark trial is a randomized, multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. The DESSOLVE II study completed enrollment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss, and achieved a strong signal of safety.
About Micell Technologies, Inc.
Micell Technologies is a biomedical company that is enhancing the performance of cardiovascular medical devices with innovative drug delivery systems. Its unique surface and polymer modification technologies enable Micell to precisely and consistently control drug elution and polymer exposure duration, creating the potential for a therapeutic solution to coronary artery disease without the long-term safety concerns of currently available drug-eluting stents. Micell also is developing a drug-coated balloon for vascular interventions. Visit us at www.micell.com.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes," and words and terms of similar substance in connection with the results of clinical trial programs and the use, safety and efficacy of the MiStent SES® in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of and expectations about future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties including, but not limited to, the following: the results of any further clinical trials and studies; including long-term follow-up of the patients that participated in the DESSOLVE I and II trials; the safety of the MiStent SES and its efficacy in controlling drug elution and limiting polymer exposure duration; our ability to obtain regulatory approval of the MiStent SES in other jurisdictions; the successful development and commercialization of the MiStent SES in Europe and other markets; the ability of the MiStent SES to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward- looking statement contained in this press release.
Micell, Micell Technologies, the Micell Logo, MiStent, and MiStent SES are among the trademarks of Micell Technologies, Inc.
Contact for Micell Technologies
Arthur J. Benvenuto, Chairman & CEO
SOURCE Micell Technologies, Inc.
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Sep. 30, 2016 04:00 PM EDT Reads: 3,574
IoT offers a value of almost $4 trillion to the manufacturing industry through platforms that can improve margins, optimize operations & drive high performance work teams. By using IoT technologies as a foundation, manufacturing customers are integrating worker safety with manufacturing systems, driving deep collaboration and utilizing analytics to exponentially increased per-unit margins. However, as Benoit Lheureux, the VP for Research at Gartner points out, “IoT project implementers often ...
Sep. 30, 2016 03:45 PM EDT Reads: 3,656
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Sep. 30, 2016 03:30 PM EDT Reads: 348
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
Sep. 30, 2016 03:00 PM EDT Reads: 548
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Sep. 30, 2016 03:00 PM EDT Reads: 3,663
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, will discuss how VPaaS enables you to move fast, creating scalable video experiences that reach your ...
Sep. 30, 2016 03:00 PM EDT Reads: 1,234
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
Sep. 30, 2016 03:00 PM EDT Reads: 3,012
In his session at @ThingsExpo, Kausik Sridharabalan, founder and CTO of Pulzze Systems, Inc., will focus on key challenges in building an Internet of Things solution infrastructure. He will shed light on efficient ways of defining interactions within IoT solutions, leading to cost and time reduction. He will also introduce ways to handle data and how one can develop IoT solutions that are lean, flexible and configurable, thus making IoT infrastructure agile and scalable.
Sep. 30, 2016 03:00 PM EDT Reads: 1,652
Creating replica copies to tolerate a certain number of failures is easy, but very expensive at cloud-scale. Conventional RAID has lower overhead, but it is limited in the number of failures it can tolerate. And the management is like herding cats (overseeing capacity, rebuilds, migrations, and degraded performance). Download Slide Deck: ▸ Here In his general session at 18th Cloud Expo, Scott Cleland, Senior Director of Product Marketing for the HGST Cloud Infrastructure Business Unit, discusse...
Sep. 30, 2016 02:45 PM EDT Reads: 2,644
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...
Sep. 30, 2016 02:45 PM EDT Reads: 652
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Bradley Holt, Developer Advocate a...
Sep. 30, 2016 02:30 PM EDT Reads: 2,465
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
Sep. 30, 2016 02:30 PM EDT Reads: 353
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Sep. 30, 2016 02:30 PM EDT Reads: 5,258
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
Sep. 30, 2016 02:15 PM EDT Reads: 1,726
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Sep. 30, 2016 02:15 PM EDT Reads: 1,162