Click here to close now.


News Feed Item

Long-Term Safety and Efficacy of MiStent SES Presented at CRT 2014

-- Rapid polymer absorption within three months coupled with drug delivery profile up to nine months provides for excellent healing --

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.


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

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 
(919) 313-2104

SOURCE Micell Technologies, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Cloud computing is unquestionably one of the driving forces of DevOps, as the automation of operations transforms enterprise software development. DevOps, however, is more than a technology trend, as it represents a move toward silo-busting, self-organizing horizontal teams that drive business velocity. At the same time, enterprise Digital Transformation represents an upheaval across the enterprise, as customer preferences and behavior drive enterprise technology decisions. This transformation ...
"eFolder does a lot of different things but we protect data and we are focused on protecting data no matter where it resides," explained Carlo Tapia, Product Marketing Manager at eFolder, in this interview at Cloud Expo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Most of the IoT Gateway scenarios involve collecting data from machines/processing and pushing data upstream to cloud for further analytics. The gateway hardware varies from Raspberry Pi to Industrial PCs. The document states the process of allowing deploying polyglot data pipelining software with the clear notion of supporting immutability. In his session at @ThingsExpo, Shashank Jain, a development architect for SAP Labs, discussed the objective, which is to automate the IoT deployment proces...
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.
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
In demand-intensive mobile and web applications, an emerging pattern is to host the Systems of Engagement in the cloud (for maximum responsiveness) but keep the Systems of Record with the other important business systems in the company datacenter, often on a tightly secured mainframe. But what about the space in between? In this IBM Redpaper publication, we show that the IBM Bluemix cloud platform offers technologies that make it easy for cloud-based SoEs to securely connect to on-premises IBM...
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
OpsHub, Inc. has announced enhanced support for DevOps and Migration for both Team Foundation Server and Visual Studio On-line in a heterogeneous environment. With added support for build and release entities in OpsHub Integration Manager (OIM) Microsoft customers can now leverage Visual Studio build and release services to manage DevOps processes in a heterogeneous environment. With the enhanced support customers can manage the DevOps process in Team Foundation Server while undertaking activit...
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
SYS-CON Events announced today that Catchpoint, a global leader in monitoring, and testing the performance of online applications, has been named "Silver Sponsor" of DevOps Summit New York, which will take place on June 7-9, 2016 at the Javits Center in New York City. Catchpoint radically transforms the way businesses manage, monitor, and test the performance of online applications. Truly understand and improve user experience with clear visibility into complex, distributed online systems.Founde...
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...