Cardica Receives FDA Clearance for Multiple Expanded Indications of World's Smallest-Profile Articulating Surgical Stapling Device
Clearance for MicroCutter XCHANGE 30 Now Covers Thoracic, Pediatric and Urologic Surgical Procedures
REDWOOD CITY, Calif., Jan 19, 2016 (GLOBE NEWSWIRE via COMTEX) --
Cardica, Inc. CRDC, today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to use its MicroCutter XCHANGE [(R)] 30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures. This clearance complements the existing indications for use of the MicroCutter XCHANGE 30 in surgical procedures in the small and large intestine and in the appendix.
Surgical staplers are routinely used in the U.S. in more than one million minimally invasive or robotically-assisted laparoscopic surgical procedures annually. At five millimeters and articulating to 80 degrees, the MicroCutter XCHANGE 30 is the smallest-profile articulating stapler available in the world. It is currently available with a white cartridge used to staple vascular and other thin tissue.
"With this important corporate and commercial milestone, the MicroCutter's U.S. indication covers many of the same indications as approved in the European Union," said Julian Nikolchev, president and CEO of Cardica. "We look forward to introducing this innovative surgical stapler in a limited launch to key opinion leaders throughout the United States, including those surgeons performing video assisted thoracic surgery (VATS) at the annual meeting of the Society of Thoracic Surgeons (STS) in Phoenix, Arizona later this month and leading pediatric surgeons at the American Pediatric Surgical Association annual meeting in San Diego in May 2016."
Mr. Nikolchev continued, "Importantly, our primary company focus will remain the completion of the development for our new combination device, while we optimize our supply chain to ensure adequate supply of the combination device at product launch."
About the MicroCutter XCHANGE 30
The MicroCutter XCHANGE 30, the world's first and only five-millimeter surgical stapler that articulates to 80 degrees, is a cartridge-based, minimally-invasive surgical stapling system. The small size and large degree of articulation enhances the surgeon's access and visualization at the surgical site. This device is designed to mitigate limitations on the advancement of minimally invasive surgical approaches created by larger stapling devices. As the smallest profile articulating stapler available today, the MicroCutter XCHANGE 30 may reduce the amount of dissection and tissue handling required to position the stapler in confined spaces, enabling access to difficult to reach anatomy.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica's MicroCutter XCHANGE [(R) ] 30, that includes a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter and staples, is manufactured and cleared for use in the United States for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix. The MicroCutter XCHANGE 30 White Cartridge staple has application in vascular tissue. In addition, Cardica manufactures and markets its automated anastomosis systems, the C-Port [(R)] Distal Anastomosis Systems and PAS-Port [(R)] Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 56,500 units throughout the world.
The statements in this press release regarding Cardica's beliefs as to the benefits expected to be obtained from the use of the MicroCutter XCHANGE(R) 30, are "forward-looking statements." There are a number of important factors that could cause results to differ materially from those indicated by these forward-looking statements, including: that Cardica may not be successful in its efforts to complete the development of the combination device or achieve optimization of the Company's supply chain for the combination device; 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, 2015, under the caption "Risk Factors," filed on November 12, 2015. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. 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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