Crux Biomedical (Portola Valley, California). a private medical device firm, reported the first U.S. implant of the Crux IVC Filter. The filter, used to prevent an often fatal pulmonary embolism (PE), was implanted at the Atlanta Medical Center by David Rosenthal, chief of vascular surgery and principal investigator of this pivotal trial.
"Crux was able to design a device that is versatile and simple to use," said Thomas Fogarty, MD, one of the founders of Crux and developer of several systems for improving cardiovascular procedures.
Every year in the U.S. about 600,000 patients develop a PE and 120,000 to 150,000 die as a result.
Crux says that the primary features of the filter are self-centering, ease of retrieval and low profile.
Rosenthal said that the filter "was extremely easy to deploy. We are excited with the devices' ability to routinely self center in the vena cava and as result, we anticipate improved retrievability. The study is being conducted at 12 U.S. centers.
Retrievable IVC filters, first introduced in the U.S. in 2002, allow either permanent implantation of the device or removal minimally-invasively once the patient is through the period when they are at risk for a PE. Filters are increasingly being used as a result of increased diagnosis of deep vein thrombosis and the protection they provide in cases of trauma and orthopedic surgeries.
Crux says that current retrievable filters offer challenges. "Tilting of an IVC filter makes subsequent retrieval very challenging and can take up to several hours to accomplish," said Frank Arko, co-founder of Crux and chief of endovascular surgery at Texas Southwestern University (Houston). He said the filter can be dceployed or removed in less than five minute.
Annual sales of IVC filter in the U.S. are estimated to be $252 million in 2008, growing between 8%-10% annually, according to Crux.
Mel Schatz, CEO of Crux, reported "encouraging results" based on feedback from U.S. and international investigators. "We are confident that we have developed an IVC filter that better meets the needs of implanting physicians."
Crux in early October reported receiving a $250,000 direct equity investment from Hercules Technology Growth Capital (Palo Alto, California), a finance company providing venture debt and equity to life science companies at all stages of development.
Schatz said, "The equity from Hercules will support our pivotal U.S. clinical trials and pioneering R&D efforts. We expect to achieve a leadership position in this growing field by providing the easiest, most versatile IVC filter."