The path to innovation is often long and full of challenges. For Corindus Vascular Robotics, the journey to develop the CorPath Vascular Robotic System took 10 years and required overcoming several engineering challenges along the way. Now, a year after receiving approval from the U.S. Food and Drug Administration, CorPath is being used in cath labs across the country, helping interventional cardiologists to precisely advance stents during percutaneous coronary intervention (PCI) procedures to treat patients with coronary artery disease.
The company’s efforts to create the CorPath System were ignited by a vision to produce technology that would assist physicians with the extreme precision required during PCI procedures. Subtle movements, often less than a millimeter, can be the difference between a successful cardiac catheterization procedure and one that requires secondary stent placement or an additional procedure at a later date. With such precision required, it’s no surprise that up to 47 percent of stents are sub-optimally placed, as noted in “Impact of Stent Deployment Procedural Factors on Long-Term Effectiveness and Safety of Sirolimus-Eluting Stents,” in the American Journal of Cardiology. These procedure variations can have a big impact, such as:
Elevating the risk of target vessel revascularization in the patient, which may require an additional procedure in the future; Increasing patient and physician radiation exposure during the placement of additional stents; and
Decreasing procedure profitability, since reimbursement is the same whether one or two stents are placed.
The premise behind developing CorPath was to create a device that would improve the precision of PCI procedures through robotic-assisted control of coronary guide wire movement, as well as the advancement of balloon and stent devices. With robotic precision, physicians could position the right stent in the right place, and potentially avoid clinical complications associated with overlapping or misplaced stents. Making CorPath a reality entailed creating a robotic bedside unit, as well as a cockpit, with a control console, for the physician to operate the system. (See Figure 1)
CorPath development began in 2002 in Israel, where the company was founded. Corindus moved its operations to Massachusetts in 2006, prompted by an investment from a Boston-based firm, and to gain greater access to valuable expertise and resources within the US marketplace.
The biggest development challenge faced was that the product crossed so many domains, requiring the company to assemble a multi-disciplined team with expertise in software, hardware, robotics, plastics, electronics, and medical devices. A determined effort successfully acquired the necessary domain expertise through hiring or contracting, but coordinating efforts among the diverse team required tremendous management of resources and time.
Initial designs focused on developing a proof-of-concept system with basic functionality for evaluation. Subsequent designs added capabilities to increase workflow and refined how the device was operated while making sure it is suitable to the busy cath lab environment. The initial designs proved that robotic assisted PCI was technically feasible, but the challenge remained of making the product effective from the perspectives of safety, usability, and economics. Safety concerns were addressed in every aspect of the design, and were evaluated during the rigorous FDA approval process.
Design Considerations and Challenges
In a traditional PCI procedure, physicians must wear heavy and cumbersome lead aprons to shield themselves from radiation as they manually advance the guide wire and place the stent. Radiation exposure is an occupational hazard for cath lab physicians. One of CorPath’s key safety features is the cockpit that allows physicians to operate the robotic arm while providing radiation shielding from the fluoroscopy that is used to view the guide wire and stent during the PCI procedure. (See Figure 2)
Clinical trials demonstrated that the system can reduce physician radiation exposure by 95 percent. The design considerations from a usability perspective were numerous, but the following highlight some of the top issues that were addressed:
Workflow: Using CorPath must enhance physician workflow, not impede it. The design and placement of controls and visual displays required clinician input to fully utilize the manual skills of physicians, enhance their workflow, and also to make the robotic controls as intuitive as possible.
Performance: Adoption would not be as successful if it increased procedure time, despite its higher accuracy and precision.
Accuracy: For the system to be successful, it had to exceed the accuracy and precision of traditional PCI procedures performed manually. A multi-disciplined team focused on refining its accuracy with each design iteration.
Product Neutrality: When the initial ideas about CorPath were formulated, the Corindus team realized that the system must accommodate the guide wires, stents, and balloons from various manufacturers. This will assist the physician to make the best decision to his patient and not be forced to a specific brand. Creating the product neutrality required designing the system to accommodate them, and then test the effectiveness of their use.
From an economic perspective, CorPath had to provide sufficient value to justify the expenditure. Many of its key attributes, specifically those relating to usability and improved patient outcomes, will help organizations realize returns on their investment. For example, reducing scenarios where a second stent must be placed will increase the profitability per procedure, and decreasing sub-optimally placed stents can reduce complications and the need for additional procedures. Ultimately, improved outcomes benefit the patient, but also help organizations with their clinical and quality ratings, which may generate increased referrals and new business.
After a series of design revisions, the company began clinical trials of CorPath in 2010 and 2011. The CorPath PRECISE Study was sponsored by Corindus under Investigational Device Exemption approval from the FDA to obtain 510(k) clearance. The study was a prospective, multicenter, open-label, non-randomized study, enrolling 164 patients at nine clinical trial sites. The study that was published in the JACC (Journal of the American College of Cardiology) found that using CorPath and when comparing to historical data, nine percent fewer stents were required per lesion, there was a 40 percent reduction in contrast media usage, and a 95 percent reduction in radiation exposure for the primary operator.
Based on the success of its clinical trial, CorPath received 510(k) approval from the FDA in July 2012. Currently, the robotic-assisted system is being used at organizations throughout the United States. Learning to use the system requires initial on-site training for physicians and cath lab staff. Users typically become proficient in using the system after completing three procedures with training supervision. (See Figure 3)
The product’s design process was a key ingredient to its success. The decade-long process uniquely focused on creating a system that would augment physician skills, not replace them.
This article was written by Tal Wenderow, Co-Founder and Executive Vice President of Business Strategy and Marketing, Corindus Vascular Robotics, Waltham, MA. For more information, visit http://info.hotims.com/49742-167.