There are also other challenges within the procedure including issues of precision and proper stent selection, a phenomenon known as longitudinal geographic miss (LGM), which is caused by sub-optimal stent placement.
Corindus Vascular Robotics is confident that its CorPath System for robot-assisted angioplasty will solve both of these problems – so much so that the company is putting money where its mouth is for hospitals that adopt the CorPath into their cath labs.
“[Corindus] was founded by interventional cardiologists for two reasons: to protect the interventional cardiologist, and to look at the needs of the [PCI] procedure and its challenges,” says Corindus's co-founder and executive VP of business strategy and marketing, Tal Wenderow. “The value of robotics is to protect the the physicians, and also to provide precision in the procedure that can elevate PCI cases.”
The CorPath System, which was cleared by FDA in 2012, places a physician within a shielded control console (an “interventional cockpit”), removed from the patient. From here the doctor is able to perform an angioplasty from a safe distance within the cath lab by controlling an articulating robot arm that sits at bedside with the patient. The clinician benefits from the precision afforded by the robotic instruments and also from the radiation protection afforded by the cockpit. Wenderow says Cordinus has seen an up to 95.2% reduction in radiation exposure to the doctor using this system.
|The CorPath system places the physician in a cockpit to control a robotic arm for a PCI procedure. (image courtesy Corindus Vascular Robotics)|
The system functions as a tool for physicians and has features to assist with measuring anatomy and precisely advancing and fixating the stent. “All of that should lead to better placement,” Wenderow says. “There are studies that correlate that to enhanced clinical outcomes.”
Controlling a robotic arm from a semi-remote cockpit sounds like something that would be great for a younger generation of doctors, the kind who play video games in their off hours, but Brett Prince, Corindus's director of marketing, says the learning curve is not steep and that even veteran doctors have easily caught on. The most important factor, Prince says, is not experience with the controls, but experience with the PCI procedure.
“What we saw in our trial was it took three cases for physicians to reach a real level of proficiency where we see a statistical drop in amount of time the procedure is taking and the amount of radiation dose they're giving to the patient,” Prince says. He adds that all hospitals who install CorPath are given FDA-approved training for staff and doctors provided by Corindus.
As part of the official rollout of CorPath, Corindus recently transmitted a live demonstration at the TCT Conference in October. Giora Weisz, director of clinical research at the Center for Interventional Vascular Therapy at Columbia University Medical Center successfully performed a PCI on a patient with multiple risk factors and severe coronary artery disease with multiple interventions. “Robotic technology is changing the way interventional cardiologists conduct PCIs,” Weisz says in a prepared statement. “I have performed more than 70 procedures using the CorPath and firmly believe in its potential to improve patient outcomes and provide a new standard of care in coronary angioplasty procedures.”
Prince adds, “Feedback from patients has been overwhelmingly positive. Patients have a perception that a robotic procedure will be done more precisely than a manual procedure, so they have a level of comfort with the technology. I think they'll seek out hospitals that provide the robotic procedure.”
Glowing endorsements aside, there is a hurdle for Corindus to overcome. In the age of Obamacare, with rising pressures to decrease healthcare costs at every level, how can the company justify the costs, training time, and the potentially significant change to angioplasty to hospitals and caregivers?
|BIOMEDdevice San Jose will be hosting a session, "A Physician's Perspective on Medical Robotics" on Dec. 5, 2013|
Wenderow says Corindus intentionally prices the CorPath at below $500K out of considerations for hospital budgets. But Prince adds that the true return on investment is in the outcomes and longer-term savings for hospitals. “The disposable and consumable elements [of the CorPath] don't add a tremendous cost to the procedure. And the opportunity to reduce stent utilization has a significant impact on the return on investment for doing a PCI,” Prince says. “The reimbursement for a patient is the same whether doctors use one stent, two stents, or even three stents. Every time you use another stent you're really decreasing the economics and profitability from a hospital perspective.”
“The national average is 1:1.21 stents to lesions. But, when you think about it, it should be 1:1,” Wenderow adds. Which is why Corindus is offering a “One-Stent Program” for participating hospitals. “Any procedure that they do with CorPath, if they use a second unplanned stent we'll give them a credit of $1000 to cover the cost,” Prince explains.
Wenderow also notes that the system can use any brand of stent. “It doesn't matter if you use Boston, Abbott, or a Medtronic stent, we can use all of them. The doctor doesn't need to change his practice and stent selection, which helps a lot with the learning curve.”
As the CorPath continues to roll out, Corindus is also looking into expanding into other fields of robot-assisted surgery including neurological applications. While some doctors have cautioned about carefully selecting patients for robot-assisted procedures, Prince says Corindus hasn't encountered any limitations in its realm yet. “We've seen a broad range of procedures being done from simple to complex PCI, but there's nothing in terms of inclusion or exclusion of patients that's specific for robots.”
Prince says for the team at Corindus, and other robotics companies, the key to gaining more adoption hospitals is in demonstrating real, valuable outcomes and championing the benefits and in providing technology that helps patients and clinicians at the same time.“It's not a trade between the two,” he says. “Data shows you can improve the clinical outcomes and improve the health of the operator.”
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