Healthcare Industry News: anastomosis
News Release - April 30, 2009
Cardica Develops the Cardica Microcutter, The First True Multi-Fire Endolinear CutterRepresents Company's Planned Expansion Beyond Cardiac Surgery into Other Major Surgical Markets with Large Potential
New Form Factor Also Would Be Smallest Available, Enabling Single-Site and Natural Orifice Surgery
REDWOOD CITY, Calif., April 30 (Healthcare Sales & Marketing Network) --Cardica, Inc. (Nasdaq: CRDC ) today announced that it is seeking to expand beyond the field of cardiac surgery and into additional surgical markets with the development of a potentially revolutionary, true multi-fire endoscopic linear microcutter based on proprietary technology developed at Cardica. Cardica has applied its knowledge and experience in automated cardiovascular staplers to develop a prototype of the Cardica Microcutter that is significantly smaller than currently commercialized endoscopic microcutters and, unlike commercialized products, can be fired multiple times without removing the device from the surgical site. Cardica has submitted several patent applications related to the Cardica Microcutter and is in discussions with multiple potential development and commercialization partners to advance further development of the Cardica Microcutter and potentially bring this significant advancement in minimally invasive surgery to surgeons and their patients.
The Cardica Microcutter is designed to cut and staple continuously, without needing to replace a spent cartridge with a new one after each deployment. The Cardica Microcutter would be fully articulating. The device is 8 mm in diameter, compared to commercialized products that are at least 12 mm in diameter, allowing access through smaller, less-invasive ports. Variants of Cardica's technology could enable shaft diameters as small as 5 mm. Because of the small size of Cardica's device, it also could enable port-access surgeries, including robot-assisted surgery, Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single-site surgical interventions, which are rapidly emerging interventional areas.
"We believe that our true multi-fire endoscopic microcutter product could redefine minimally invasive surgery, potentially resulting in significant improvements in surgical techniques, time and cost savings and ultimately in improved patient outcomes," said Bernard Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "The Cardica Microcutter is designed to offer significant advantages to currently available products and has the potential to be used in many applications, including in general, gynecologic and bariatric surgery."
Potential advantages of the Cardica device include the ability to:
- Place up to seven successive staple deployments without needing to remove the Microcutter from the surgical site; in contrast, currently available devices require the deployment tool to be removed from the surgical site for cartridge reload after each deployment; this requires 11 individual steps for replacement of each cartridge;
- Facilitate less invasive laparoscopic surgical approaches through a significant size reduction and ability to access difficult-to-reach areas via a flexible shaft design; and
- Dissect, clamp, coagulate and cut like conventional closure devices when combined with bi-polar coagulation technology; this could result in giving surgeons the option to switch between stapling and sealing with the push of a button and could reduce the need for surgeons to use as many as three different modalities during surgery, thereby reducing costs and significantly improving ease of use.
About Surgical Stapling Devices and Cardica's Technology
Today, general surgeons extensively use stapling devices to dissect and connect tissue in bowel, abdominal and pulmonary surgical procedures. In contrast, 20 years ago, hand-sewn sutures were used for virtually all of these procedures.
The worldwide market for laparoscopic surgery products is estimated at $3.6 billion per year, with endoscopic staplers and cutters representing nearly $1 billion of this market. Endoscopic staplers and cutters have applications in numerous surgical specialties, including colorectal, bariatric, gynecological, urology and thoracic surgery.
Cardica has developed products that could revolutionize revascularization through the adoption of Cardica systems that use an automated device to deploy tiny, stainless steel staples to attach the end of a bypass vessel graft to a coronary artery, a connection known as an anastomosis. This connection is often considered the most critical step of coronary artery bypass graft (CABG) surgery. Cardica has developed automated anastomosis systems for use in the most difficult settings, including robot-assisted, minimally invasive closed-chest cardiac bypass surgery. In this surgery, anastomoses are completed using Cardica's system inserted through small incisions in the chest cavity that create finger-size ports. Cardica is now applying this technology to the broader surgical market.
Cardica is a leading provider of automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica's products provide cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure. Cardica's C-PortŪ Distal anastomosis Systems are marketed in the United States and Europe and its PAS-PortŪ Proximal anastomosis System is marketed in the United States, Europe and Japan.
This press release contains "forward-looking" statements, including all statements with respect to the future development and therapeutic and commercial potential of the Cardica Microcutter. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "planned," "potential," "would," "seeking," "could," "believe" and similar expressions are intended to identify 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 develop the Cardica Microcutter and expand its product portfolio, that Cardica's current and any future products may never gain any significant degree of market acceptance, that any future Cardica products face regulatory, reimbursement and manufacturing risks, that Cardica's intellectual property rights may not provide adequate protection and that Cardica will need substantial additional funding and may be unable to raise capital when needed, which would force Cardica to delay, reduce or eliminate its research and development programs or commercialization efforts, 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 fiscal quarter ended December 31, 2008. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
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