Welcome!

News Feed Item

Cardica Begins Shipping MicroCutter XCHANGE™ 30 Commercial Units For Europe

-- European Clinical Trial to Use Commercial Version of MicroCutter XCHANGE 30 --

REDWOOD CITY, Calif., Dec. 26, 2012 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that it shipped its first commercial MicroCutter XCHANGE™ 30 devices and cartridges to DACH Medical Group, its distributor for Germany, Austria and Switzerland. The MicroCutter XCHANGE 30 is the smallest commercially-available, cartridge-based cutting/stapling device designed to be used during laparoscopic and thoracoscopic surgical procedures.

The initial shipment of the XCHANGE 30 is intended to serve hospitals in Switzerland and Austria. Approximately 60 surgeons have used the XCHANGE 30 in over 220 laparoscopic and thoracoscopic procedures with more than 600 deployments over the last eight months. The MicroCutter XCHANGE 30 has been used in a wide variety of surgical procedures including appendectomies, gastric bypasses, hemicolectomies, gastrectomies, parenchymal or soft organ surgeries (operations on the liver and kidney), lobectomies, and other thoracic and lung surgeries. Recently, it has been used in hysterectomies as well.

Based on the performance of the MicroCutter XCHANGE 30 to date, Cardica believes the XCHANGE 30 is ready to be sold commercially. Cardica is initiating European commercial sales in a well-controlled, focused sales effort in parallel with data collection for a planned US regulatory submission. Cardica will continue to make enhancements and improvements to the MicroCutter XCHANGE 30 based on feedback from surgeons.

"Moving from development to commercialization of the XCHANGE 30 marks a significant accomplishment for Cardica, and the beginning of a new phase of growth.  We continue to focus on ensuring each surgeon has positive and successful experiences with our device," said Bernard A. Hausen, M.D. Ph.D., president and chief executive officer of Cardica, Inc. "We believe the XCHANGE 30 provides a technology advancement over larger stapler sizes which have hindered further innovation in surgical procedures."

European Clinical Trial Update

In addition to beginning commercial efforts, Cardica will use the commercial version of the XCHANGE 30 in the remaining patients enrolled in its European clinical trial designed to support regulatory clearance of the XCHANGE 30 in the United States. To date 90 patients have been enrolled. The company expects enrollment to resume in January. Cardica has added two new sites for its clinical trial in order to complete enrollment of 160 patients in the first calendar quarter of 2013, as expected.   

About the MicroCutter XCHANGE 30: The World's First and Only Five Millimeter Stapler

The MicroCutter XCHANGE 30 is a minimally-invasive stapling device designed to be used in laparoscopic and thoracoscopic surgical procedures. Its small, five-millimeter shaft diameter and range of motion up to 80 degrees of articulation differentiate the XCHANGE 30 from other commercially-available staplers. The device uses reloadable cartridges with a 30-millimeter staple line length. The cartridge comes with either blue staples, for medium tissue thicknesses, or white staples, for thin tissues such as vascular structures.

Laparoscopic procedures today are primarily performed through trocars ports, or small tubes inserted into incisions, that are between five and 10 millimeters in diameter. Prior to the introduction of the XCHANGE 30, to accommodate conventional stapling technology surgeons use 12 or 15 mm trocars, which can result in significant post-operative pain, port site infections or ventral hernias. The small size of the XCHANGE 30 may reduce the amount of tissue dissection necessary to position the stapler for deployment and may greatly improve access and visualization at the stapling site. The smaller diameter and much greater articulation, or range of motion, of the XCHANGE 30 are designed to allow easier access through smaller, less-invasive ports, and to enable faster and easier access to reach difficult anatomy during advanced laparoscopic procedures.

About Cardica 

Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 42,900 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XCHANGE™ 30, a cartridge-based microcutter device with a five-millimeter shaft diameter that is commercially available in the European Union, and the Cardica MicroCutter XPRESS™ 30, a true multi-fire laparoscopic stapling device. Both MicroCutter devices are designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 30 and XPRESS 30 products require 510(k) review and are not yet commercially available in the U.S. 

Forward-Looking Statements

The statements in this press release regarding the intended use of initial shipments of the XCHANGE 30, Cardica's belief that the XCHANGE 30 is ready to be sold commercially,  that it is beginning of a new phase of growth, its intention to continue to make enhancements and improvements to the MicroCutter XCHANGE 30, its plans to add two new sites for its European clinical trial and commence enrollment in the clinical trial in January 2013 and complete enrollment in the first quarter of 2013, its intention to continue to be focused on ensuring each surgeon has a positive and successful experience with the device, and the benefits of the small size of the XCHANGE 30, are "forward-looking statements." The words "intend," "will," "believe," "may" and "plan" and derivations of these words are intended to identify these forward-looking statements. There are a number of important factors that could cause Cardica's results to differ materially from those indicated by these forward-looking statements, including that Cardica may not be successful in its efforts to further develop or commercialize the XCHANGE 30 or its planned MicroCutter product line on its anticipated timeframe, or at all, due to regulatory, technical, manufacturing or financial difficulties; that Cardica products may face development, regulatory, reimbursement and manufacturing risks; that Cardica's intellectual property rights may not provide adequate protection; and that general business and economic conditions may impair Cardica's ability to market and develop products, or raise additional funds needed to complete development, as well as other risks detailed from time to time in Cardica's reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. Investors are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.

SOURCE Cardica, 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
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Unless you don’t use the internet, don’t live in California, or haven’t been paying attention to the recent news… you should be aware that self-driving cars are on their way to becoming a reality. I have seen them – they are real. If you believe in the future reality of self-driving cars, then continue reading on. If you don’t believe in the future possibilities, then I am not sure what to do to convince you other than discuss the very real changes that will roll out with the consumer producti...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...