REDWOOD CITY, Calif.--(BUSINESS WIRE)--Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and commercializing the Dextera MicroCutter 5/80™ Stapler, today announced that several leading surgeons highlighted the use of Dextera’s C-Port® Distal and PAS-Port® Proximal Anastomosis Systems as well as the MicroCutter 5/80 Stapler in a variety of less invasive surgical procedure presentations at the 14th Annual International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) meeting, held in Rome, Italy.
“Dextera’s complete product line was featured in several presentations at the ISMICS meeting this year, showcasing the ability of our products to help enable less invasive cardiothoracic surgical procedures to improve patient outcomes,” said Julian Nikolchev, president and CEO of Dextera Surgical. “Importantly, in addition to growing demand for the MicroCutter 5/80, we are experiencing a renewed interest in our cardiac products from key opinion leaders based on patient requests for minimally invasive surgeries.”
Cardiac Anastomosis Product Presentations
Two oral presentations featured Dextera’s automated anastomosis devices as an enabling tool for minimally invasive coronary bypass procedures. An anastomosis is the joining of two vessels together and is critical to a successful coronary bypass procedure. Dextera’s cardiac products are the only automated anastomosis products on the market today.
On Wednesday, June 7 during the Minimally Invasive Coronary Artery Bypass Graft (CABG) session, Mahesh K. Ramchandani, M.D., vice chair of cardiovascular surgery at Houston Methodist Hospital, demonstrated the use of the PAS-Port System to facilitate a minimally invasive direct coronary artery bypass (MIDCAB) procedure.
Also on June 7, Husam H. Balkhy, M.D., director of the Robotic and Minimally Invasive cardiac surgery program at the University of Chicago Medicine, gave an invited presentation at the Masters session on Hybrid Coronary Artery Bypass Graft (CABG), Endovascular Coronary Skills, and Anastomotic Connectors session highlighting the use of the C-Port System to connect the bypass graft during totally endoscopic robotic cardiac surgery.
“The need for a hand-sewn anastomosis during a robotic bypass procedure has been one of the biggest factors preventing wider adoption of Totally Endoscopic Coronary Artery Bypass (TECAB) procedures to date,” commented Dr. Balkhy. “I have been using the only available automated anastomosis tool - the C-Port Flex-A® System - to precisely and reliably connect the graft to the coronary artery, and eliminate the need for a hand-sewn anastomosis. This device allows me to perform TECAB procedures more safely and in a broader range of patients in a much less invasive manner.”
The C-Port device was also featured in three other presentations in the cardiac surgery plenary session on Thursday June 8. Dr. Balkhy presented a paper detailing the use of the device to effectively execute the TECAB procedure on high risk patients; Dr. Hiroto Kitahara presented on the robotic cardiac surgery experience at the University of Chicago and highlighted the importance of the C-Port Flex A in robotic TECABs; and, Dr. Diego Avella presented a video of a unique case of combined robotic left lobectomy and TECAB using the C-Port device which allowed the patient to be discharged in 2 days. In addition, the device was described as being necessary for the execution of robotic TECABs in two posters presented at the meeting by the University of Chicago team.
MicroCutter 5/80 Presentations
On Thursday, June 8, Joel Dunning, M.D., of James Cook University Hospital, presented “VATS Microlobectomy: How do I do it” to demonstrate his unique approach to performing minimally-invasive lobectomies. This invited lecture was part of the Thoracic Masters Class, a session designed to provide specific instruction on the procedures expected to advance minimally invasive surgery. On Saturday, June 10, during session 1 of the Thoracic Movie Day, Marco Nardini, M.D., also of James Cook University Hospital, presented “Microlobectomy, with Day 1 Discharge,” to demonstrate that many patients go home the day after Microlobectomy surgery. Both presentations highlighted the use of the MicroCutter 5/80 to help enable Microlobectomy procedures.
About the C-Port® Distal Anastomosis Systems (C-Port systems)
In the United States, the C-Port Anastomosis Systems are intended for use in the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. The C-Port systems – the C-Port xA system and the Flex-A® system – can be used on- or off-pump and create compliant anastomoses that expand and contract with blood flow. The C-Port systems work on coronary arteries as small as 1.3 millimeters in internal diameter and work with grafts of various diameters and vessels with single wall thicknesses less than 0.75 millimeters. The Flex-A system allows surgeons to position the device to create a secure connection even in difficult to reach areas of the heart.
About the PAS-Port® Proximal Anastomosis System
In the United States, the PAS-Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts. The PAS-Port system is a fully-automated device used to perform an anastomosis between a saphenous vein and the aorta during either on- or off-pump CABG surgery. The PAS-Port system has been used in Japan and Europe since 2004, and received 510(k) clearance in the United States in 2008. The PAS-Port system allows a surgeon to complete an automated connection of the bypass graft vessel to the aorta (known as a proximal anastomosis) without the need to clamp and manipulate the aorta. The common method of completing a proximal anastomosis in CABG surgery often requires that the aorta be clamped and utilizes time-consuming hand-sewn sutures. When the clamp is released, tiny blood clots or particles from the aortic wall can be released, which can then travel to the brain and cause stroke and other neurologic complications. In addition, the PAS-Port's unique design allows for a comparable take-off angle when compared to hand-sewn sutures, and the PAS-Port's implant design does not introduce metal into the graft lumen.
MicroCutter Indication Information
The MicroCutter 5/80 Stapler and MicroCutter 30 Reloads are 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 5/80 may be used with both MicroCutter 30 White Reloads in vascular/thin tissue and MicroCutter 30 Blue Reloads for standard tissue.
About Dextera Surgical
Dextera Surgical (Nasdaq:DXTR) designs and manufactures proprietary stapling devices for minimally invasive surgical procedures. In the U.S., surgical staplers are routinely used in more than one million minimally invasive laparoscopic, video-assisted or robotic-assisted surgical procedures annually.
Dextera Surgical also markets the only automated anastomosis devices for coronary artery bypass graft (CABG) surgery on the market today: the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System. These products, sold by Dextera Surgical under the Cardica brand name, have demonstrated long-term reliable clinical performance for more than a decade.
The statements in this press release regarding the expected future benefits the MicroCutter 5/80, C-Port and PAS-Port devices 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 the risks detailed from time to time in Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, under the caption “Risk Factors.” Dextera Surgical 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 Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.