San Clemente-based ICU Medical Inc. is cutting one of its products from the U.S. market.
ICU makes needleless intravenous connectors and other medical devices, including those used in handling cancer drugs.
The company recently said it would voluntarily discontinue domestic distribution of its CLC2000, a “positive displacement needle-free connector” for use with intravenous catheters. Positive displacement refers to the positive pressure of fluid movement from a reservoir into a catheter upon disconnecting a syringe or other equipment.
Regulatory concerns and falling demand led ICU to a decision to end sales in the U.S. on April 30.
The Food and Drug Administration recently expressed concerns over the safety of devices such as the CLC2000 in a letter Susan Gardner, director of the office of surveillance and biometrics in the FDA’s Center for Devices and Radiological Health, sent to infection control practitioners. Gardner wrote that the agency is requiring nine companies, including ICU, to conduct post-market studies on positive displacement connectors to assess whether they may be associated with a higher rate of bloodstream infections compared with other types of needleless connectors.
Gardner noted that there have been “multiple clinical reports since 2006” that have shown an association between the use of positive displacement needleless connectors and an increase in infections.
She also said, however, that parameters of the study made it “difficult to judge the true risk of [device-associated bloodstream infections] associated with positive displacement connectors.”
ICU said it chose to remove CLC2000 from the U.S. market “rather than invest in an expensive study of an outdated technology.”
CLC2000 was introduced 16 years ago and will still be available overseas, the company added.
Among the other companies included in the FDA’s post-market surveillance study are Bethlehem, Pa.-based B. Braun Medical Inc., a unit of Germany-based B. Braun Melsungen AG that employs nearly 1,400 workers in Orange County; and Baxter Healthcare Corp., a unit of Chicago-based Baxter International Inc.
The FDA hasn’t, at this point, recommended any changes in the usage of positive displacement catheters, Gardner wrote.
ICU indicated that it’s ready with other products to offer in place of the CLC2000, which have “largely been replaced in the U.S.” by doctors who are using more updated devices with what are known as “neutral displacement features,” which prevent blood from flowing into a catheter upon connection or disconnection.
The company counts two of the updated devices— MicroClave Clear and Neutron Catheter Patency—in its current product lineup.
MicroClave Clear and Neutron are available in “sufficient quantities” to start to transition all of the company’s existing U.S. CLC2000 customers immediately, according to Richard Costello, ICU’s vice president of sales.
Glaukos Gets Noticed
Laguna Hills-based startup Glaukos Corp.’s 2012—particularly the FDA approval of its iStent implant for treating glaucoma last June—is gaining notice in the financial and technology press.
Glaukos’ iStent restores the natural physiologic outflow of the eye that is interrupted by glaucoma, which is a leading cause of blindness.
Author Suresh Gupta, writing on the Seeking Alpha website, mentioned that the venture-backed company received a top 100 North America tech startup award from Red Herring last year.
Red Herring’s award honors “the year’s most promising private technology ventures,” Gupta wrote, adding that Glaukos was the only North American medical device company that was nominated for the honor.
Red Herring said in a release that its list “has become a mark of distinction” for identifying new companies and entrepreneurs. Some of its previous picks: Facebook, Twitter, Google, Yahoo, Skype, Salesforce.com, YouTube (which is now part of Google) and eBay.
Auxilio Contract
Mission Viejo-based document and image management specialist Auxilio Inc. has received a five-year, $4.5 million contract from Covina-based hospital operator Citrus Valley Health Partners.
Auxilio helps hospitals and healthcare providers cut their dependence on paper records.
Citrus Valley owns three hospitals, has 3,000 workers and 1,000 affiliated physicians. The facilities are Citrus Valley Medical Center-Queen of the Valley in West Covina, Foothill Presbyterian Hospital in Glendora, and Citrus Valley Medical Center-Inter-Community in Covina.
Bits and Pieces:
Michael Aldridge has been named senior vice president, corporate strategic development for Anaheim-based drug maker Questcor Pharmaceuticals Inc., a new position. Aldridge previously was chief executive of Xenome Limited, an Australia-based biopharmaceutical company. … Laguna Beach-based trade group Healthcare Billing & Management Association said that it is presenting a compliance conference for medical billing companies from March 3 to 5 at the Westin South Coast Plaza. The conference is intended on helping attendees develop and assess organizational compliance plans. Association members provide a variety of business support services for physician practices, including processing insurance claims.
