|By Business Wire||
|November 15, 2012 03:58 PM EST||
Cook Medical has received U.S. Food and Drug Administration (FDA) marketing approval for the first devices in its Zilver® PTX® Drug-Eluting Peripheral Stent portfolio, company officials reported today. It’s the first time the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery.
“This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “No other company can match Cook’s commitment to this technology, and by the end of 2013, we expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to U.S. physicians.”
The Zilver PTX Drug-Eluting Stent is intended to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA).
In order to supply as many physicians as possible with this new technology, Cook is making Zilver PTX available initially in 80 mm lengths in 6 mm and 7 mm diameters. The products indications for use also allow two Zilver PTX 80 mm stents to be overlapped to treat longer lesions up to 140 mm. The FDA approval also includes 40 mm and 60 mm lengths, which will be introduced to the U.S. early in 2013. Cook expects to receive regulatory approval for 120 mm length stents in both diameters next year.
Data from Cook’s pivotal clinical trial indicate:
- Eight out of ten patients treated with Zilver PTX still had open arteries (primary patency) after one year1. That compares to only 3 out of 10 patients treated with angioplasty alone.
- Patients who received a bare metal stent required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX. 2
“After conducting the largest randomized controlled study of peripheral stenting ever undertaken, we now see remarkable results in patients treated with Zilver PTX,” said Michael Dake, M.D., a professor in the Department of Cardiothoracic Surgery at Stanford University School of Medicine and medical director of the Cath/Angio Laboratories at Stanford Medical Center, Palo Alto, Calif.
“With this approval, treating PAD in the U.S. will begin to undergo the same revolution that drug elution did for treating coronary artery disease,” added Gary Ansel, M.D., director for the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio, and an assistant clinical professor of medicine in the Department of Internal Medicine at the University of Toledo Medical Center in Toledo, Ohio. “Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide.”
Cook’s Zilver PTX stent is already approved for sale in more than 50 markets, including the European Union, Japan, Brazil and most of South America, Australia, New Zealand and Taiwan. The device is being introduced to the U.S. market in a five-step process designed to make this technology available to as many patients as possible initially.
(Drs. Dake and Ansel, who served as global principal investigators for the Zilver PTX clinical trial, are paid consultants to Cook Medical with respect to its medical devices.)
About Zilver PTX
How does Zilver PTX work?
A physician gains arterial access through the groin and guides a Zilver PTX stent to the narrowed artery with a catheter. The stent is deployed and expands like a scaffold to help keep the artery open after the catheter is withdrawn. The drug paclitaxel, which coats the stent, is taken up by the cells of the arterial wall to help prevent the renarrowing of the artery over time.
What are the main features of the device?
A combination therapy device, Zilver PTX both restores patency (blood flow) and provides targeted delivery of paclitaxel, a cell growth-limiting drug proven to reduce arterial restenosis (post-procedural blockages). This drug coats the stent without the use of a polymer, eliminating risks that may arise directly from a polymer. Zilver PTX is made of nitinol, a "shape memory" metal alloy, and is engineered to withstand the dynamic forces of the superficial femoral artery (SFA). Zilver PTX is the first peripheral vascular device that combines the mechanical support of stenting with the drug paclitaxel to reduce the risk of restenosis.
What data supports the efficacy of Zilver PTX?3
Two-year data from the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease indicate that the stent demonstrated 74.8 percent primary patency at 24 months in the PTX group, compared to just 57.8 percent for patients with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study.
What are other current means of treatment for PAD?4
Current treatment options for PAD include lifestyle changes, medication, exercise, angioplasty, bare metal stenting and bypass surgery.
What is Zilver PTX indicated for and what are the risks and contraindications for this device?
INDICATIONS: indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4mm to 7mm and total lesion lengths up to 140 mm per limb and 280 mm per patient. CONTRAINDICATIONS: Women who are pregnant, breastfeeding, or plan to become pregnant in the next 5 years should not receive a Zilver PTX Drug-Eluting Peripheral Stent. Patients who cannot receive recommended anti-platelet and/or anti-coagulant therapy. Patients judged to have a lesion that prevents proper placement of the stent or stent delivery system. WARNINGS: Persons with allergic reactions to nitinol may suffer an allergic reaction to this implant • Persons allergic to paclitaxel may suffer an allergic reaction to this implant • The safety and effectiveness of implanting more than four Zilver PTX Drug Eluting Peripheral Stents in a patient has not been clinically evaluated. PRECAUTIONS: To avoid involvement of the common femoral artery, the proximal end of the stent should be placed at least 1 cm below the origin of the superficial femoral artery. To avoid involvement of the below-the-knee popliteal artery, the distal end of the stent should be placed above the plane of the femoral epicondyles • This product is intended for use by physicians trained and experienced in diagnostic and interventional vascular techniques. Standard techniques for interventional vascular procedures should be employed • Manipulation of the Zilver PTX Drug-Eluting Peripheral Stent requires fluoroscopic control • Do not try to remove the stent from the introducer system before use • Ensure that the red safety lock is not inadvertently removed until final stent release • Deploy the stent over an extra stiff or ultra stiff wire guide • Do not push the hub toward the handle during deployment • Do not expose the delivery system to organic solvents (e.g., alcohol) • Do not use power injection systems with the delivery system • Do not rotate any part of the system during deployment • The device is intended for single use only. Do not resterilize and/or reuse this device • Repositioning of the device after deployment is not possible since the introducer catheter cannot be re-advanced over the stent once deployment begins. POTENTIAL ADVERSE EVENTS: Potential adverse events that may occur include, but are not limited to Allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium • Allergic reaction to nitinol • Arterial aneurysm • Arterial rupture • Arterial thrombosis • Arteriovenous fistula • Atheroembolization (Blue Toe Syndrome) • Death • Embolism • Hematoma/hemorrhage • Hypersensitivity reactions • Infection • Infection/abscess formation at access site • Ischemia requiring intervention (bypass or amputation of toe, foot or leg • Pseudoaneurysm formation • Renal failure • Restenosis of the stented artery • Stent embolization • Stent malapposition • Stent migration • Stent strut fracture • Vessel perforation or rupture • Worsened claudication/rest pain. Paclitaxel: Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events, not described in the above source, may be unique to the paclitaxel drug coating, including • Allergic/immunologic reaction to the drug coating • Alopecia • Anemia • Blood product transfusion • Gastrointestinal symptoms • Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) • Hepatic enzyme changes • Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis • Myalgia/Arthralgia • Myelosuppression • Peripheral neuropathy
About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving 41 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn.
1 ,2 Dake M., et. Al, Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease: Twelve Month Zilver PTX Randomized Study Results. Circulation: Cardiovascular Interventions, August 5, 2011
2 Dake M. Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease: Two Year Results, Presented at International Symposium on Endovascular Therapies (ISET), January 17, 2011, Miami Beach, Florida
3 Dake M. Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease: Two Year Results, Presented at International Symposium on Endovascular Therapies (ISET), January 17, 2011, Miami Beach, Florida
4 National Institute of Health, National Heart Lung and Blood Institute. How Is Peripheral Arterial Disease Treated? http://www.nhlbi.nih.gov/health/health-topics/topics/pad/treatment.html. Accessed August 10, 2012
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud.
Apr. 21, 2015 04:30 AM EDT Reads: 1,912
SYS-CON Events announced today that StorPool Storage will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. StorPool is distributed storage software that allows service providers, enterprises and other cloud builders to run data storage on standard x86 servers, instead of using expensive and inefficient storage arrays (SAN).
Apr. 21, 2015 04:00 AM EDT Reads: 2,052
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquired by Aditi Technologies. He is a Microsoft Regional Director for Hyderabad, India, and one of the f...
Apr. 21, 2015 04:00 AM EDT Reads: 1,323
SYS-CON Events announced today that kintone has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business application (BYOA) platform, and workflow automation system.
Apr. 21, 2015 03:00 AM EDT Reads: 1,568
SYS-CON Events announced today that Site24x7, the cloud infrastructure monitoring service, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Site24x7 is a cloud infrastructure monitoring service that helps monitor the uptime and performance of websites, online applications, servers, mobile websites and custom APIs. The monitoring is done from 50+ locations across the world and from various wireless carriers, thus providing a global perspective of the end-user experience. Site24x7 supports monitoring H...
Apr. 21, 2015 02:30 AM EDT Reads: 1,921
SYS-CON Events announced today that Intelligent Systems Services will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Established in 1994, Intelligent Systems Services Inc. is located near Washington, DC, with representatives and partners nationwide. ISS’s well-established track record is based on the continuous pursuit of excellence in designing, implementing and supporting nationwide clients’ mission-critical systems. ISS has completed many successful projects in Healthcare, Commercial, Manufacturing, ...
Apr. 21, 2015 02:15 AM EDT Reads: 2,501
SYS-CON Events announced today that B2Cloud, a provider of enterprise resource planning software, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. B2cloud develops the software you need. They have the ideal tools to help you work with your clients. B2Cloud’s main solutions include AGIS – ERP, CLOHC, AGIS – Invoice, and IZUM
Apr. 21, 2015 02:00 AM EDT Reads: 3,320
WebRTC is an up-and-coming standard that enables real-time voice and video to be directly embedded into browsers making the browser a primary user interface for communications and collaboration. WebRTC runs in a number of browsers today and is currently supported in over a billion installed browsers globally, across a range of platform OS and devices. Today, organizations that choose to deploy WebRTC applications and use a host machine that supports audio through USB or Bluetooth can use Plantronics products to connect and transit or receive the audio associated with the WebRTC session.
Apr. 21, 2015 02:00 AM EDT Reads: 1,720
The best mobile applications are augmented by dedicated servers, the Internet and Cloud services. Mobile developers should focus on one thing: writing the next socially disruptive viral app. Thanks to the cloud, they can focus on the overall solution, not the underlying plumbing. From iOS to Android and Windows, developers can leverage cloud services to create a common cross-platform backend to persist user settings, app data, broadcast notifications, run jobs, etc. This session provides a high level technical overview of many cloud services available to mobile app developers, includi...
Apr. 21, 2015 02:00 AM EDT Reads: 682
The WebRTC Summit 2015 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
Apr. 21, 2015 01:45 AM EDT Reads: 2,330
SYS-CON Events announced today that Tufin, the market-leading provider of Security Policy Orchestration Solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. As the market leader of Security Policy Orchestration, Tufin automates and accelerates network configuration changes while maintaining security and compliance. Tufin's award-winning Orchestration Suite™ gives IT organizations the power and agility to enforce security policy across complex, multi-vendor enterprise networks. With more than 1...
Apr. 21, 2015 01:45 AM EDT Reads: 3,435
As enterprises move to all-IP networks and cloud-based applications, communications service providers (CSPs) – facing increased competition from over-the-top providers delivering content via the Internet and independently of CSPs – must be able to offer seamless cloud-based communication and collaboration solutions that can scale for small, midsize, and large enterprises, as well as public sector organizations, in order to keep and grow market share. The latest version of Oracle Communications Unified Communications Suite gives CSPs the capability to do just that. In addition, its integration ...
Apr. 21, 2015 01:30 AM EDT Reads: 4,066
SYS-CON Events announced today that Cloudian, Inc., the leading provider of hybrid cloud storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cloudian, Inc., is a Foster City, California - based software company specializing in cloud storage software. The main product is Cloudian, an Amazon S3-compliant cloud object storage platform, the bedrock of cloud computing systems, that enables cloud service providers and enterprises to build reliable, affordable and scalable cloud storage solu...
Apr. 21, 2015 01:00 AM EDT Reads: 2,520
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
Apr. 21, 2015 12:45 AM EDT Reads: 4,438
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada. Our partner network encompasses some 300 of the world's leading systems integrators and security s...
Apr. 21, 2015 12:00 AM EDT Reads: 5,017
BroadSoft on Tuesday announced that it is a recipient of the 2014 Frost & Sullivan Market Leadership Award in the Hosted/Cloud Internet Protocol (IP) Telephony market for Latin America. According to Frost & Sullivan market research, the Latin America (LATAM) hosted/cloud Internet Protocol (IP) telephony market, including integrated unified communications and collaboration (UC&C) applications, is currently experiencing a rapid growth trajectory and is expected to exhibit a tenfold rise in annual revenues in the 2013-2020 period. With more than 600 cloud deployments internationally, BroadSoft w...
Apr. 21, 2015 12:00 AM EDT Reads: 2,100
In 2015, 4.9 billion connected "things" will be in use. By 2020, Gartner forecasts this amount to be 25 billion, a 410 percent increase in just five years. How will businesses handle this rapid growth of data? Hadoop will continue to improve its technology to meet business demands, by enabling businesses to access/analyze data in real time, when and where they need it. Cloudera's Chief Technologist, Eli Collins, will discuss how Big Data is keeping up with today's data demands and how in the future, data and analytics will be pervasive, embedded into every workflow, application and infra...
Apr. 20, 2015 10:45 PM EDT Reads: 990
Participants will reach the final if their IoT solution is liked. A community vote will determine the best solutions submitted in each country, after which an expert jury will select the national winners and the best international IoT solution. Each country's best solution can win a national marketing campaign worth up to €30,000 and become a partner in Deutsche Telekom's participating markets. The winning international solution can become partner of Deutsche Telekom Group across all eight countries and reach out to a potential of 10,8 million business customers. Deutsche Telekom Group has a...
Apr. 20, 2015 05:00 PM EDT Reads: 868
Health care systems across the globe are under enormous strain, as facilities reach capacity and costs continue to rise. M2M and the Internet of Things have the potential to transform the industry through connected health solutions that can make care more efficient while reducing costs. In fact, Vodafone's annual M2M Barometer Report forecasts M2M applications rising to 57 percent in health care and life sciences by 2016. Lively is one of Vodafone's health care partners, whose solutions enable older adults to live independent lives while staying connected to loved ones. M2M will continue to gr...
Apr. 20, 2015 03:00 PM EDT Reads: 1,131
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements around Unified Networks, Cloud Computing strategies, Virtualization around Software defined Data Ce...
Apr. 20, 2015 02:00 PM EDT Reads: 1,487