SYS-CON MEDIA Authors: Carmen Gonzalez, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

News Feed Item

First Patients Enrolled in a Clinical Study of Drug Coated Chocolate® Balloon

Second Generation drug coated balloon designed to address both acute and long-term outcomes

PLEASANTON Calif. and SINGAPORE, March 24, 2014 /PRNewswire/ -- TriReme Medical LLC, a subsidiary of Singapore based QT Vascular Ltd. announced today that the first three patients were enrolled in a clinical study of its unique drug-coated Chocolate® PTA balloon. Dr. Andrew Holden, co-Principal Investigator of the study, performed these procedures at Auckland City Hospital, in Auckland, New Zealand.

The drug-coated Chocolate® clinical study is a single arm trial that will enroll a minimum of 30 patients at up to four centers in New Zealand and Germany. The trial will evaluate the rate of procedural success immediately after treatment as well as persistence of positive outcomes at 6 and 12 months post procedure. All key outcomes of the trial will be evaluated by independent core laboratories.

The drug-coated Chocolate® PTA balloon is designed for the treatment of patients with vascular disease in their legs, known as peripheral arterial disease (PAD). The drug-coated Chocolate® PTA balloon is unique in that it combines the acute benefits of the FDA and CE approved Chocolate® PTA balloon with paclitaxel-based coating, an anti-proliferative drug proven to reduce the build-up of tissue in the vessel that can occur months after the original procedure. The underlying Chocolate® PTA balloon platform has demonstrated a very low rate of dissections and bail out stenting in clinical studies (1).  

"The first three complex cases in this study highlight the advantages of the underlying Chocolate® platform in creating a larger and more uniform lumen while minimizing vessel trauma," stated Dr. Andrew Holden, Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine.

"First Generation drug-coated balloons are based on Plain Old Balloon Angioplasty (POBA) technology that goes back more than 30 years.  POBA is well known to induce significant vessel trauma and often requires adjunctive stenting to complete the procedure," added Dr. Eitan Konstantino, President and CEO, TriReme Medical. "The mere addition of a drug does not solve this issue. The drug coated Chocolate® PTA balloon is the only product that is designed to address both the acute trauma and long term results."

About Peripheral Arterial Disease
Peripheral artery disease (PAD) is caused by the build-up of fatty substances that collect and adhere to the linings of the arteries, in a process known as atherosclerosis. The build-up causes the internal lining of the artery to thicken, narrowing the artery and limiting blood flow to vital tissues and organs. Commonly affected arteries include those located in the legs, arms, neck and kidneys. The vast majority of patients with PAD also have significant concomitant coronary artery disease (CAD) and a high proportion of morbidity and mortality in these patients is related to myocardial infarction, ischemic stroke or cardiovascular death. PAD is estimated to affect 202 million people worldwide (2).

About TriReme Medical, LLC
TriReme, a subsidiary of Singapore based QT Vascular Ltd., is an emerging leader in the development and commercialization of next generation minimally invasive devices for the treatment of complex arterial disease. The company is focused on the US and the emerging Asian markets.

(1) Das T for Mustapha J. Chocolate® Bar, Leipzig Interventional Course, 28-31 January, 2014.

(2) "Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis." 19 Oct 2013. The Lancet.

SOURCE TriReme Medical, LLC

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
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
What do a firewall and a fortress have in common? They are no longer strong enough to protect the valuables housed inside. Like the walls of an old fortress, the cracks in the firewall are allowing the bad guys to slip in - unannounced and unnoticed. By the time these thieves get in, the damage is already done and the network is already compromised. Intellectual property is easily slipped out the back door leaving no trace of forced entry. If we want to reign in on these cybercriminals, it's hig...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. 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 development cycles that produce software that is obsolete...
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...