Abstract
Californian Surgical Stapling Specialist Cardica, Inc. has announced the suspension of enrollment in its European clinical trial of the MicroCutter XPRESS 30 due to a small subset of deployments where the XPRESS 30 did not perform satisfactorily in thicker tissue. The company has isolated the underlying cause, which requires modifications to the product. There have been no serious adverse events and all patients have had an uneventful postoperative course as it relates to the use of the MicroCutter.
Background
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. The company’s MicroCutter XPRESS 30, a true multi-fire laparoscopic stapling device is designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter products are not yet commercially available in the U.S. The Cardica MicroCutter XCHANGE 30 and XPRESS 30 are not currently commercially available.
Actions
In view of the problem Cardica has reprioritized the development activities of its MicroCutter product line to emphasize the development of the MicroCutter XCHANGE 30. In addition to the acceleration of development for the XCHANGE 30, the company intends to pursue modifications of the XPRESS 30 concurrently. Cardica plans to continue the trial with the XCHANGE 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, by the end of the first calendar quarter of 2012, once this device completes development and design verification, and Cardica is able to apply a CE Mark to the device.
The surgical indications for the trial will not change, with thicker tissue resections and anastomosis intended to be added in the latter part of the trial once the XPRESS 30 modifications have been completed and verified. In light of Cardica’s limited financial resources, Cardica has suspended development of other potential products in its planned microcutter product line until the development of XCHANGE 30 has been completed and additional financial resources have been obtained.
Company comments
“We are disappointed that the XPRESS 30 did not perform as well as we expected in the upper range of tissue thickness but understand and are confident we can make the changes needed to enhance performance. In the interim, the XCHANGE 30 will allow us to resume trial enrollment in the near future while also providing Cardica with a readily marketable product that is substantially smaller with significantly enhanced articulation range,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. “At this time, we believe that rapidly advancing our smallest, cartridge-based device, the XCHANGE 30, through development and into a clinical trial, while addressing the underlying issue with the XPRESS 30, will allow us to reach the European and US markets with our premier product in the most efficient manner.”
Source: Cardica
published: January 15, 2012 in: Cardio, Clinical Studies/Trials, Companies, General Surgery, Gynaecology/Obstetrics, Regulatory