Novate Medical has announced that the first patient has been enrolled in its SENTRY IDE Study, designed to evaluate the safety and efficacy of Novate’s novel bioconvertible Sentry™ Inferior Vena Cava (IVC) Filter.
Based in Galway, Ireland, Novate Medical is focused on developing novel IVC filter devices for the prevention of pulmonary embolism (PE) in patients at transient PE risk.
The Sentry IVC Filter is the first bioconvertible IVC filter. It is designed to provide protection from PE during the period that a patient is at risk and then bioconvert to a non-filtering configuration after a minimum of sixty 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.
The SENTRY study is a prospective, single-arm, multi-centre study designed to evaluate Approximately 135 patients at transient risk of pulmonary embolism (PE) are being enrolled at up to 25 sites in the US and internationally. The primary endpoint of the study is the composite rate of clinical success of the Sentry IVC Filter at six months.
Souheil Saddekni MD, Professor of Vascular and Interventional Radiology at the University of Alabama, Birmingham performed the procedure and stated; “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”. SENTRY’s Principal Investigator, Michael Dake MD, Stanford University Medical Center, Stanford CA 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.”
Chas Taylor, co-founder and Executive Chairman of Novate said “This is a very important milestone for Novate. We would like to express our appreciation to Dr Saddekni and all of the clinical team at UAB for assisting us to achieve our goal. We look forward to completing enrolment in this study in the near future.”
Source: Novate Medical