CorPath GRX

As of 29 October 2019, Siemens Healthineers now owns Corindus Vascular Robotics—developer of a robot-assisted system (CorPath) for interventional coronary and vascular procedures. A press release reports that, prior to the closing of the acquisition, 87.5% of Corindus’ stakeholders approved the purchase. It adds that the company is now part of Siemens’ Advanced Therapies reporting segment. The initial acquisition announcement, published in August 2019, stated that Siemens would pay $1.1 billion for all fully diluted shares of Corindus.

Mark Toland, former president and CEO of Corindus, says that the acquisition combines Siemens Healthineers’ “strong medical technology portfolio with its digital platforms and solutions” with Corindus’ “precision robotics platform”. He adds that this combination “has the potential to transform healthcare delivery so that, together, we can provide better care at lower cost”. According to the press release, Toland will continue to manage the business with Siemens.

The technology

CorPath is the only robotic system that has both FDA and CE mark approval for endovascular peripheral and coronary interventions. The system, as of March this year, is also CE-mark approved for neurovascular interventions. It is designed to enable physicians to remotely control catheters, guidewires, balloons and stents via integrated imaging.

Tejas M Patel (Apex Heart Institute, Ahmedabad, India) and colleagues write in EClinicalMedicine (a Lancet publication) that “the primary advantage” of the system is a “marked reduction in radiation exposure to the interventional cardiologist of up to 97%”. They explain that, with CorPath, the operator performs the procedure from a lead-shielded robotic workstation “usually placed several feet from the patient in the cardiac catheterisation laboratory”; the authors add that this means that the operator does not have to wear “heavy, lead-lined protective garments” and, therefore, potentially has a lower risk of the orthopaedic injuries that are associated with such garments.

While reduced radiation exposure is currently seen as the key selling point of the system, according to Patel et al, the system also has potential to be used to perform interventional procedures from a “long-distance remote location using secure mainstream internet at generically available connection parameters”. “Such an achievement would be a major step forward in making interventional revascularisation treatment available to patients with coronary artery disease in remote or under-developed areas,” the authors observe.  

Two feasibility studies have already evaluated the use of CorPath to perform remote (i.e. the operator is in different location from the patient) percutaneous coronary intervention (PCI). One of these was an animal study in which the operator was located 166km away, and the other was a human study in which the operator was in an adjacent room to the patient. The positive outcomes of these studies prompted Patel et al to conduct their feasibility study of remote robotic PCI. In their study, the operator was located 20 miles away from the cath lab.

Patel et al report that, in the cath lab, the in-lab interventional cardiologist obtained vascular access (via the radial or femoral artery) and introduced a 6F introducer sheath while the scrub technician helped to prepare the procedure. The remote operator advanced the balloon guidewire, advanced the balloon catheter, and (after success predilatation of the stenosis) deployed a stent. The primary endpoint was procedural success with no major adverse cardiac events (MACE) and the secondary endpoint was technical device success.

Overall, Patel et al evaluated the use of the CorPath system in five patients, and the primary and secondary endpoints were achieved in all patients. All patients were free of MACE at 24 hours after the procedure and all patients were haemodynamically stable and asymptomatic at discharge. “The results of this study represent a milestone in the development of remote robotic PCI in that they open myriad possibilities for remote interventional treatment of coronary artery disease in underdeveloped countries or in any rural area that does not have ready access to an interventional cardiologist or a local hospital that specialises in emergency cardiovascular care,” the authors comment.

They also observe that a remote robotic interventional system could also have benefits for stroke patients as well coronary artery disease patients, noting that there are “wide gaps” in the availability of acute neurointerventional therapeutic facilities. “Effective utilisation of remote telerobotic surgery could hypothetically provide a major part of the solution to these deficits after feasibility and safety are established,” Patel et al state. The CorPath system does already have CE mark approval (as of July 2019) for neurovascular procedures.

Siemens Healthineers has not made any definitive statements about the direction it wants to take the robotic system in. However, Bernd Montag, CEO of Siemens, says: “With the completion of the acquisition [or Corindus], we are opening up a new field for our Advanced Therapies business, tapping into adjacent growth markets with great potential for the future. We are taking an important step forward in the upgrading of our 2025 strategy.”