A biotech company has announced the completion of the second in a successful series of structural heart navigation animal studies.
Cleveland Clinic‘s Heart, Vascular and Thoracic Institute evaluated the feasibility of applying Centerline Biomedical‘s augmented reality image guidance technology to navigate structures in a beating heart.
The investigational 4D-GNC (guidance, navigation and control) technology builds upon the company’s flagship IOPS product.
The team of physicians and engineers were able to accomplish a number of key interventional tasks during this live animal study.
This included transseptal puncture to cross from the right to the left side of the heart, navigating catheters into all four chambers, and accessing key structures such as the left atrial appendage and pulmonary veins.
Heart disease
Structural heart disease is a multi-billion-dollar market which suffers from the limitations of x-ray fluoroscopy and the need for multiple concomitant imaging modalities to complete certain procedures.
Not only is navigating complex cardiac structures and device placement challenging, but the reliance on fluoroscopy also creates radiation exposure risk to the patient, physician, and staff.
Azeem Latib, section head of interventional cardiology and structural heart disease at Montefiore Health System, said: “Growth in this clinical field is advancing at a rapid pace, but the unsolvable piece has been fully integrating medical devices with enhanced navigation to improve safety and outcomes.”
The technology
The navigation technology is designed to work in tandem with fluoroscopic x-ray imaging, but many of the tasks were accomplished using the 4D-GNC prototype alone.
The precise real-time navigation through a moving structural heart map, synchronised to the EKG signal, made it straightforward to perform complex tasks, said Vikash Goel, Centerline Biomedical’s chief technology officer.
Rishi Puri, a coronary and structural heart interventional cardiologist at the Cleveland Clinic’s Heart, Vascular and Thoracic Institute, served as principal investigator for this study and plays a key role guiding the company’s structural heart disease strategy as a scientific advisor.
“Dr Puri was able to effortlessly navigate the entire heart using a novel, sensorised steerable catheter, changing its shape on the fly, without relying on fluoroscopy or echocardiography even within difficult-to-reach structures such as the right-sided pulmonary veins,” said Goel.
“This success gives us confidence that our technology will scale to a broad range of specialists to allow navigation with minimal radiation, minimal contrast media and minimal dependence on concomitant imaging modalities.”
Centerline Biomedical is rapidly growing as it commercialises its FDA-cleared Intra-Operative Positioning System product at leading US hospital systems.
“The remarkable accomplishments witnessed today exceeded all expectations and will certainly prove to be a watershed moment for the company,” said CEO Phil Rackliffe.
“Moments like these are only enabled by high-performing teams, acting on market insights, focused on a shared mission.”
