First Patient Enrolled in United States Study of Novate's Sentry IVC Filter

September 22, 2014—Novate Medical announced the beginning of enrollment in the SENTRY investigational device exemption (IDE) study, a prospective, single-arm, multicenter study designed to evaluate the safety and efficacy of the company’s novel bioconvertible Sentry inferior vena cava (IVC) filter.

The SENTRY study is enrolling approximately 135 patients at transient risk of pulmonary embolism (PE) at up to 25 sites in the United States and internationally. The primary endpoint of the study is the composite rate of clinical success of the Sentry IVC filter at 6 months.

According to the company, the bioconvertible Sentry IVC filter is designed to provide protection from PE during the period that a patient is at risk and then bioconvert to a nonfiltering configuration after a minimum of 60 days. This feature removes the requirement for an additional interventional procedure to retrieve the device. In addition, Sentry has a cylindrical frame that is designed to reduce the reported complications of existing IVC filter technologies, including tilt, migration, fracture, and vessel perforation.

SENTRY’s principal investigator is Michael Dake, MD, of Stanford University Medical Center in Stanford, California. Souheil Saddekni, MD, professor of vascular and interventional radiology at the University of Alabama at Birmingham, enrolled the first patient in the study.

In the company’s press release, Dr. Dake commented, “I am delighted that the SENTRY study is underway. The Sentry IVC filter is a truly novel device, which potentially will change the way we manage patients at transient risk of PE. We hope to be able to show that the device design reduces the known complications of IVC filters while removing the need for a retrieval procedure.”

Dr. Saddekni added, “The Sentry device performed well in the procedure and appears to offer a novel alternative in the prevention of PE. Interestingly, the patient considered the removal of the need for a second procedure to be an important factor during the process of consent. We are pleased to contribute this first case in this important study.”