FDA approves Clear Guide Scenergy, CT-ultrasound fusion system
February 22, 2016
By: Dana Bentley, Contributing Reporter
Clear Guide Medical has received FDA approval for its CT-ultrasound fusion and image guidance system, the Clear Guide Scenergy. The device, which functions as an accessory to most ultrasound machines, enables clinicians to perform interventional and diagnostic procedures with the benefits of both imaging modalities simultaneously.
“The main use case is CT-guided biopsy or ablation, where the patient goes into the CT several (3-8) times as the surgeon seeks the target and aligns the needle using his or her acquired skills," Dorothee Heisenberg, CEO of Clear Guide Medical, told HCB News.
With the Scenergy, the surgeon just scrolls through the CT images as though they were live, and so it’s easier to get to the target and doesn’t require as many passes through the CT (one to put the VisiMARKERs on the patient, and one to confirm the success of the biopsy or treatment), according to Heisenberg.
For patients, benefits include not only fewer CTs, but access to a wider pool of physicians who can perform these procedures. Heisenberg said, “The needle guidance and CT-ultrasound fusion make it possible for more physician[s] to do them (e.g. not having to drive 300 miles from home in some remote states to get to a Tier 1 hospital for diagnosis or treatment)."
Two of the primary shortcomings of current fusion systems are lengthy registration processes and registration error due to patient respiration and position changes. Scenergy was designed with both of these challenges in mind, featuring automated registration and continuous updating during procedures, greatly lessening the impact of patient movement on targeting.
To help end users understand the capabilities of the system, Clear Guide Medical created the following introductory video:
“We are constantly updating the marker to marker registration, and so motion is less of a problem," said Heisenberg, although she acknowledges that they have not yet eliminated the problem entirely.
In a study that has not yet been published, Clear Guide Medical tested whether a CT-ultrasound fusion technique could improve accuracy for novice, intermediate, or expert ultrasound operators in targeting prostate and kidney lesions.
By measuring the distance from the needle tip to the center of the target, novice and intermediate operators displayed a statistically significant difference (p=0.03) in accuracy between ultrasound (19.7 mm) vs CT-ultrasound fusion (5.1 mm). For the expert operator, accuracy was similar for the two techniques (5.67 mm vs 4 mm), with slightly better accuracy using only ultrasound.
Now that the device has FDA clearance, further studies are planned.
The company intends to continue developing features and adding new imaging modalities to its fusion system, including MR.
“Our next project involves Cone Beam CT, and there are many other features that will be added over time, including tracking multiple ablation antennae simultaneously, and modeling lung motion for better biopsies,” said Heisenberg.
Clear Guide Medical has received FDA approval for its CT-ultrasound fusion and image guidance system, the Clear Guide Scenergy. The device, which functions as an accessory to most ultrasound machines, enables clinicians to perform interventional and diagnostic procedures with the benefits of both imaging modalities simultaneously.
“The main use case is CT-guided biopsy or ablation, where the patient goes into the CT several (3-8) times as the surgeon seeks the target and aligns the needle using his or her acquired skills," Dorothee Heisenberg, CEO of Clear Guide Medical, told HCB News.
With the Scenergy, the surgeon just scrolls through the CT images as though they were live, and so it’s easier to get to the target and doesn’t require as many passes through the CT (one to put the VisiMARKERs on the patient, and one to confirm the success of the biopsy or treatment), according to Heisenberg.
For patients, benefits include not only fewer CTs, but access to a wider pool of physicians who can perform these procedures. Heisenberg said, “The needle guidance and CT-ultrasound fusion make it possible for more physician[s] to do them (e.g. not having to drive 300 miles from home in some remote states to get to a Tier 1 hospital for diagnosis or treatment)."
Two of the primary shortcomings of current fusion systems are lengthy registration processes and registration error due to patient respiration and position changes. Scenergy was designed with both of these challenges in mind, featuring automated registration and continuous updating during procedures, greatly lessening the impact of patient movement on targeting.
To help end users understand the capabilities of the system, Clear Guide Medical created the following introductory video:
“We are constantly updating the marker to marker registration, and so motion is less of a problem," said Heisenberg, although she acknowledges that they have not yet eliminated the problem entirely.
In a study that has not yet been published, Clear Guide Medical tested whether a CT-ultrasound fusion technique could improve accuracy for novice, intermediate, or expert ultrasound operators in targeting prostate and kidney lesions.
By measuring the distance from the needle tip to the center of the target, novice and intermediate operators displayed a statistically significant difference (p=0.03) in accuracy between ultrasound (19.7 mm) vs CT-ultrasound fusion (5.1 mm). For the expert operator, accuracy was similar for the two techniques (5.67 mm vs 4 mm), with slightly better accuracy using only ultrasound.
Now that the device has FDA clearance, further studies are planned.
The company intends to continue developing features and adding new imaging modalities to its fusion system, including MR.
“Our next project involves Cone Beam CT, and there are many other features that will be added over time, including tracking multiple ablation antennae simultaneously, and modeling lung motion for better biopsies,” said Heisenberg.