Cardica (Redwood City, California) stockholders shouldn't have been surprised yesterday when the company said it plans to expand beyond the field of cardiac surgery and into additional surgical markets with the development of a multi-fire endoscopic linear microcutter.

According to Bernard Hausen, MD, PhD, president/CEO of Cardica, the company has been saying for quite some time now that it would introduce products outside its core business of automated anastamosis development.

Now, Hausen told Medical Device Daily, "we're far enough along and confident enough in our IP and technology" to disclose what that [new] device is. He said the Cardica Microcutter is significantly smaller than endoscopic microcutters currently on the market and, unlike other commercialized products, will be able to be fired multiple times without removing the device from the surgical site.

"The endo-stapling market is already a very well established market with a full adoption of the surgical population and in need of new technology to advance the field," Hausen said, the new microcutter proposed to fill that need.

The two major players already in this field are Covidien (Mansfield, Massachusetts) and Ethicon Endo-Surgery (Cincinnati), a business of Johnson & Johnson (New Brunswick, New Jersey). Covidien sells a variety of surgical staplers under its Autosuture brand, and its product line also includes both circular and linear staplers. Ethicon makes a circular stapler for the surgical treatment of hemorrhoids, as well as linear staplers and cutters for colon resection and gastric bypass.

According to Cardica, currently available devices require the stapler to be removed from the surgical site for cartridge reload after each deployment. This requires a total of 11 steps for what the company calls "the reload shuffle," Hausen said.

"In the laparoscopic procedures ... you can imagine how difficult it would be to find exactly the same spot where you left off." In contrast, the Cardica Microcutter is capable of placing up to seven successive staple deployments without needing to remove the device from the surgical site, the company says.

"Our technology is based on a very, very different, novel way of stapling," Hausen said. "It allows the surgeon to just continue stapling without removing the product from the abdominal cavity. That has enormous implications in terms of time and ease of use and also a great implication in terms of cost ... so by having technology where you just continue firing with one device rather than having to replace cartridges, theoretically it could have a cost advantage."

Hausen told MDD that the ability to fire multiple times from one tool, without exchanging it, is based on technology – Cardica's technology – "that cannot just be duplicated by using existing technology. It is a totally different way of stapling." He said current stapling technology has a limitation in that the IP that has been filed is reaching the end of its patent life. Once the patent life expires, he expects there will be a lot more players in the field.

"That will be a strong driving force for some of the major players to dramatically innovate this field and I think the technology we've developed has the potential to do just that."

According to the company, the Cardica Microcutter 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, the company noted.

Because of the small size of Cardica's device, it also could enable several other applications, such as port-access surgeries, including robot-assisted surgery; Natural Orifice Transluminal Endoscopic Surgery (NOTES); and single-site surgical interventions, Hausen said.

Cardica said it has submitted several patent applications related to the Cardica Microcutter and is in discussions with multiple potential development and commercialization partners to advance development of the device and potentially bring it to market.

"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," Hausen said. "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."

Cardica puts the worldwide market for laparoscopic surgery products at an estimated $3.6 billion a year, with endoscopic staplers and cutters representing nearly $1 billion of this sector. Endoscopic staplers and cutters have applications in multiple surgical specialties, including colorectal, bariatric, gynecological, urology and thoracic surgery.

"Improvements in endoscopic linear cutters have been very limited since these instruments were introduced more than 15 years ago, said Paresh Shah, MD, a general surgeon and chief of Laparoscopic Services at Lenox Hill Hospital (New York). We believe that the use of Cardica's multi-fire technology in our practice could result in significant time and cost savings. A smaller, true multi-fire endocutter would also greatly enhance our ability to advance emerging fields of less invasive surgery, such as Single-Site Laparoscopy and NOTES procedures."

In its core business, Cardica provides automated anastomosis systems for coronary artery bypass graft surgery. Its C-Port distal anastomosis systems are marketed in the U.S. and Europe, and its PAS-Port proximal anastomosis system is marketed in the U.S., Europe and Japan.

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