Robotic Catheterization For Cardiac Arrhythmias
Check off electromagnetism as another in a long line of technologies used extensively by the defense industry that has now found favor in medical application.
The Catheter Guidance Control and Imaging (CGCI) system from Magnetecs Corp. navigates a catheter tip via electromagnetic technology to better target radiofrequency (RF) ablation therapy during cardiology-electrophysiology procedures.
Dr. Eli Gang
“This is a real-time navigational system that offers a rapid, safe and accurate means of treating cardiac rhythm disturbances in a manner that heretofore has not been available,” says company chief medical officer Eli Gang, clinical professor of medicine at the University of California, Los Angeles’ medical school.
Any patient with a cardiac rhythm disturbance who requires catheter ablation is a potential candidate for CGCI, according to Gang. This currently represents in excess of over 200,000 surgical cases annually in the US alone, with a potential market of roughly $15 billion, and over five million cases globally.
Magnetecs CEO Josh Shachar
Magnetecs’ co-founder, Josh Shachar, who serves as company president, CEO, and chief technology officer, has worked with the US Department of Defense since 1981, interacting with aerospace and military suppliers that use electromagnetic products. “With the end of the Cold War, I was looking for an area in which military capabilities could be expanded to civilian use,” says Shachar, who was intrigued by minimally invasive cardiac procedures using catheters. “I thought there was a better way to perform these procedures than simply pushing catheters manually within the heart, and I believed using electromagnetic forces would be an improvement.”
By coincidence, Gang met Shachar in 2003 when Gang was taking care of one of Shachar’s family members with a cardiac condition at a Los Angeles hospital. Gang and Shachar discussed the possibility of using Shachar’s expertise in magnetic to navigate catheters for electrophysiology procedures.
Previously, Shachar had founded Engineered Magnetics Inc. (a military aerospace company) and subsequently, in 2005, Pharmaco-Kinesis Corp. (advanced drug-delivery systems).
Magnetecs has 52 patents, 17 of which are issued. A substantial portion of the company is also owned by an undisclosed strategic partner who is a major player in electrophysiology.
The CGCI system is composed of an array of eight electromagnets mounted on a steel frame that the patient’s bed slides into, positioning the frame to surround the torso. The frame provides a focused distribution of the magnetic field within the appropriate heart chamber. Separately, a magnetically protected, integrated x-ray unit is housed within the system’s steel framework.
Once the patient is properly positioned, the disposable catheter with a magnetic tip is inserted into the heart chamber. The CGCI system is able to robotically guide the catheter in real-time to map and ablate the patient’s heart. A remote joystick connected to powerful computers enables the clinician in the control room to manipulate the movement of the catheter, relative to the joystick’s movement. Says Gang, “The dexterity of the physician using a joystick has been demonstrated one-to-one in real-time to the movement of a catheter within the heart of the patient.”
“Our catheter is identical in size and length to catheters used today by physicians for the manual nonrobotic approach,” Gang says. “The major difference is that the terminal 20 centimeters of our catheter are extremely floppy and soft, so it can be instantaneously manipulated by external electromagnetic forces.” The tip of the catheter is embedded with small permanent magnets used to provide torque, force, and rotation.
Once the catheter is placed inside the appropriate heart chamber, it is moved around by the external magnetic forces and creates a three-dimensional image of the cardiac structure of interest. “This image is integrated into our system and becomes part of the CGCI navigation capability,” Gang says. The physician directs the catheter again using the joystick and directs the robotic external electromagnets to the desired portion of the heart where the therapy needs to be delivered.
Once the targeted treatment area has been identified and mapped, the console in the control room is able to create the lesion characteristics on the screen. “The CGCI robotic system can automatically acquire the selected targets and perform surgical procedures,” he says. “The location is preserved dynamically as the catheter moves in and out.”
The procedure varies in length from one to five hours, depending on the particular rhythm disorder being treated. “Our hope is that by using this very precise robotic system, we will be able to significantly shorten these lengthy procedures,” states Gang. He also points out that the precision of the robotic system would replace the currently steep learning curve and eye-hand coordination required to move a catheter manually.
Later this year, Magnetecs will release results of the first human clinical study of the CGCI system, conducted at La Paz Hospital in Madrid, Spain.
The system’s two major competitors are the Niobe magnetic navigation system from Stereotaxis Inc. and the Sensei X robotic catheter system from Hansen Medical Inc., which uses passive magnets and an electromechanical system, respectively.
“Although both of these systems are considered robotic, they lack the intuitive relationship between the system and its operator, whereas, with CGCI, the system reduced the dexterity of the physician to machine language,” Shachar says.
CE mark for CGCI is expected in the third quarter of 2011, followed by 501(k) in late 2012. The system will begin selling in Europe and the Far East in late 2011, at a price of around $1.5 million, through a network of distributors, for which no new insurance reimbursement schedule is needed. US sales will be delayed until 2013, in concert with the undisclosed strategic partner, again with no need for a new reimbursement code.
Magnetecs has raised $15 million in two completed rounds of financing. A Series C, in the amount of roughly $10 million, is expected to close in June, funded by high-net-worth individuals and institutional firms. A D round of $25 million should close by the end of 2011, targeting the undisclosed strategic partner and institutions.
The company is pursuing other strategic partnerships in the fields of gastroenterology (diagnostics and therapeutics) and neurology (removal of solid tumors, intractable epileptic seizures). “We are also developing a variety of microelectromechanical tools to allow for cutting and sewing during minimally invasive procedures,” Shachar says.