Corindus Launches PRECISION Registry As Safety Of Robotic Surgery Questioned

Espicom View: With the current controversy surrounding robotic surgical systems that is coming to light, this registry will give Corindus Vascular Robotics a platform to prove the safety of its FDA-cleared system. While its device is not widely spread or used in as many different surgeries as some other available systems, Corindus will still have to deal with the stigma of robotic systems causing complications in simple surgeries. In order to increase uptake of its system, Corindus will have to instill consumer confidence, and trial results so far have been positive. However, until a standardised reporting system that captures all faults with robotic systems is released, confidence in robotic systems may not increase, leaving Corindus participating in a market that is faced with declining uptake.

Corindus Vascular Robotics has commenced the PRECISION registry, an ongoing study aimed at collecting data on the patterns of use, safety and effectiveness in the delivery and manipulation of percutaneous coronary intervention (PCI) devices. This registry will collect data from sites across the US to study the use of the CorPath robotic system in routine clinical practice. Dr Giora Weisz, Associate Professor of Medicine at Columbia University Medical Center, will lead the study.

Dr Weisz, stated that although manual PCI procedures are a widely accepted practice, there exists an opportunity for improvements to be made in stent size selection and precision movements that can only be offered with robotic assistance. He further added that they have seen initial clinical indications linked to the benefits of robotics during the CorPath PRECISE clinical trial.

While angioplasty procedures remain one of the most frequently performed procedures in the US, with nearly 1mn cases annually, the procedure has remained largely unchanged for decades. Corindus' CorPath 200 system is believed to be the first and only FDA-cleared technology that enables precise, robotic-assisted angioplasties to open arteries and restore blood flow in patients with coronary artery disease. During a CorPath angioplasty procedure, the interventional cardiologist sits in the radiation-shielded interventional cockpit. Using robotic precision, the interventional cardiologist advances stents and guidewires via a joystick with millimetre by millimetre precision. CorPath may improve clinical outcomes by enabling precise measurement of the anatomy, which could potentially lead to better stent placements.

As a result of the increasing interest in the CorPath system, Corindus has grown its patent portfolio to now include more than 30 issued patents worldwide. Additionally, following FDA clearance in July 2012, Corindus has increased its workforce, including an expansion of its sales team, and has recently relocated its office to a larger facility in Waltham, MA. The CorPath open-platform technology and intellectual property will enable Corindus to address other segments of the vascular market, including peripheral, neuro and structural heart applications.

Corindus' system is one of many robotic systems that are entering the market. The number of robotic assisted surgeries increased rapidly when the systems were first introduced. However, recently, concerns have been raised over the use of these systems. A number of studies have been conducted investigating the reporting of complications resulting as a use of robotic systems. According to Johns Hopkins Medicine, reporting of robotic surgery complications are haphazard and yield an untrue picture of safety. Complications in robotic surgery are often not reported and the FDA MAUDE database is not believed to hold a complete catalogue of events that are related to the robotic systems. The procedures most commonly associated with death were gynaecologic (22 of the 71 total reported deaths), urologic (15 deaths) and cardiothoracic (12 deaths). The cause of death was most often excessive bleeding. In cases where patients survived, hysterectomy by far had the most complications (43% of injuries). A number of surgeons have complained about the lack of tactile feedback from robotic systems, inability to tell the firmness of where they are cutting makes it difficult to ensure that they are making the appropriate incisions. The under reporting seen with robotic surgical systems could be due to the lack of clarity as to whether the system or the surgeon was at fault.

The system that has been available the longest, Intuitive Surgical's da Vinci system, has amassed the largest number of complaints. According to Intuitive Surgical, as of December 31 2012, there were 2,585 da Vinci Systems installed in approximately 2,025 hospitals worldwide. Approximately 450,000 da Vinci procedures were performed in 2012, up approximately 25% compared with the 360,000 procedures performed in 2011. For H113, growth has slowed slightly, with procedure uptake up by 18%; however, with an increasing number of safety reports being released, this growth is likely to be impaired. System sales decreased in Q213, down to US$215.9mn from US$229.4mn in Q212. Total da Vinci unit sales went down from 150 in Q212 to 143 in Q213. The trend of system sales decrease might be mirrored with the number of procedures in the near term if the safety issues are not addressed.

Intuitive Surgical has stated that during H113, there have been a number of factors that have resulted in slower than expected growth in US procedures. The company believes that the impact of each factor on procedure volumes is difficult to quantify, but includes decreased hospital admissions as reported by certain customers; quality notifications issued by Intuitive Surgical and the recent media; and, the difficulty associated with consolidating geographically dispersed patients into established robotic surgery programmes as benign hysterectomy passes through the midpoint of its adoption. Intuitive Surgical believes that reduced procedure growth coupled with the economic hardship that reduced admissions creates, adversely impacted system purchases in Q213. The company is expecting growth in procedures to continue at a level below 2012 and could decline further.

According to Intuitive Medical, during H113, various print, television and internet media released pieces questioning the patient safety and efficacy associated with da Vinci surgery, the cost of da Vinci surgery relative to other disease management methods, and the adequacy of surgeon training. In addition, Intuitive Surgical is currently named as a defendant in approximately 33 individual product liability lawsuits. Plaintiffs' attorneys are engaged in growing and well-funded national advertising campaigns soliciting clients who have undergone da Vinci surgery and claim to have suffered an injury, and have seen a substantial increase in these claims. However, the recent negative media may have and could continue to delay or adversely impact procedure adoption, system sales, and revenue growth in future periods.

Mazor Robotics also has a system for robotic-assisted surgery, Renaissance. This company's system is intended for use in spinal surgeries. Corindus' system is also used in different surgeries to that of Intuitive Surgical's. Most of the reported adverse events relate to Intuitive Surgical's da Vinci system. This could be due to the system being available longer, more widely spread or used more often. However, this reputation of the system has tainted robotic surgical systems, and companies will now have to prove that their systems are safe and do not result in complications that will require further surgeries or surgeon intervention.

If the complications are caused by the surgeon, increased training by the companies may be needed. Although, if a lot of training is needed to prevent the complications and the success rate in operations using a robotic system is similar to that in traditional surgical procedures, a benefit will not be seen when using these systems. With the current controversy surrounding robotic surgical systems, Corindus will have to prove the safety of its device in order to secure consumer confidence. If this registry is successful, it will likely be a stepping stone in proving that CorPath is safe and effective.

This article is tagged to:
Sector: Medical Devices
Geography: United States

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