"The future of surgery is not about blood and guts; the future of surgery is about bits and bytes.”
/Dr. Richard Satava/

Sunday, August 21, 2011

Robotic surgery presented biased

In mid May, an article was publishe in the Journal for Healthcare Quality, "Robotic Surgery Claims on United States Hospital Websites". It got fairly big media attention, discussed as "Hospitals Misleading Patients" (here and here as well).
The study provided the analysis of "400 random U.S. hospital websites as of June 2010. Data was collected on the presence and location of robotic surgery information on a hospital’s website; use of images or text provided by the manufacturer; use of direct link to manufacturer website; statements of clinical superiority; statements of improved cancer outcome; mention of a comparison group for a statement; citation of supporting data and mention of specific risks." It got to some interesting results:
"Forty-one percent of hospital websites described robotic surgery. Among these, 37% percent presented robotic surgery on their homepage, 73% used manufacturer-provided stock images or text, and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group. No hospital website mentioned risks."
They concluded that:
  • Many hospital websites overestimate the benefits and underestimate the risks of robotic
    surgery, potentially misinforming patients and encouraging them to undergo robotic surgery.
  • The prominent placement on a hospital website and the use of emotional appeal obscures
    the lack of support for clinical claims.
  • The widespread use of manufacturer-provided images and text raises concerns about conflicts of interest. Stock materials, produced for advertisement purposes, can be understandably one
    dimensional, even claiming that robotic surgery is the ‘‘most effective’’ or ‘‘ideal’’ therapeutic option for patients. 
And some recommendations:.
  • Hospitals should be conscientious of their role as a trusted medical adviser, and ensure that information provided on their website represents the best available evidence.
  • Hospitals should make it transparent when they are using materials provided by a manufacturer and avoid endorsing brand-name medical technologies. 
  • If hospitals are unable to provide patient-friendly, objective information about a certain treatment option, they should direct patients to a third-party source of information and encourage patients to learn about alternatives.
  • Hospital websites should present balanced medical information, accurately stating risks and benefits.
FDA has recently started to look into these issues, and primarily aims to improve the clearance procedures. Naturally, some voices raised in favor of robotic surgery, urging for better information sharing. Due to the recent installation of data-collection boxes with certain da Vinci robots and the wide-spread use of the system, we should see large-scale, evidence-based studies on robot surgery benefits rolling out in the near future.

Source: J. for Healthcare Quality

Monday, August 15, 2011

ROBODOC advances--the story of an FDA approval

I was happy to cover the FDA approval of the ROBODOC almost 3 years ago. Since then, a lot of effort has been put into the field. It's time to look back on this historical event.
The clearance procedure of the system was quite long and full of edifying stories. It was the first system that tried to get through the clearance procedure, and it was forced into the PMA category, since no equivalent technology existed.
  • October 1992, the FDA granted an IDE approval to conduct limited clinical trials (at Sutter General Hospital in Sacramento).
  • November 7., the world’s first robotic joint replacement surgery was performed .
  • A biomedical engineer for the FDA outlined comprehensive investigative testing designed to test the safety of the robotic control software.
  • In 1993, ISS began the PMA clearance procedure. The ROBODOC software and hardware had to comply with robust motion control restrictions to prevent accidental tissue and bone damage.
  • In 1996, it received the European CE mark and approval for Total Hip Arthroplasty (THA) procedures.
  • In 2002, the FDA re-assigned the ROBODOC system to its 510(k) path. Unfortunately, by this time, ISS no longer had sufficient capital to support the procedure.
  • By 2004, the significant R&D cost related to further testing and re-submission caused ISS to cease operations.
  • In November 2007, all assets and IP were transferred Curexo Technology Corporation, and $12M were invested to continue the business.
  • The fresh money allowed to finish trials, and to complete the robot’s commercialization via FDA 510(k).
  • In August 2008, the system finally received a 510(k) clearance from FDA. 
Throughout these years, all the FDA-cleared surgical robots (e.g., da Vinci, NeuroMate, CyberKnife, ROBODOC, MAKO Arm, SpineAssist) went down the 510(k) procedure, proven to be substantially equivalent to existing technologies. FDA’s emphasis has gradually shifted from the robotic technology itself to approving the results of the use of the robotic systems. It is now believed that the equivalence stands between the already-approved surgical techniques and the results attained through robotic interventions. 

Thursday, August 11, 2011

ROBODOC advances--historical timeline

The ROBODOC was the first robot to perform automated procedure on humans. Despite it clinical relevance and advanced features, it had not sold well enough to sustain the business of ISS. Now, with CUREXO's investment and effort, it may finally get into a competitive shape. The first concept of the new design can be seen on the right. A timeline of the V1 system development:

Dr. Paul and Dr. Bargar develop the baseline ROBODOC concept.
Dr. Paul performs joint replacement surgery on canines using ROBODOC.
IBM invests $3M (USD) in ISS.
ISS development team receives prestigious Computerworld Smithsonian Award for Innovation in the Arts and Sciences for Medicine.
Clinical trials of the ROBODOC system begin.
Dr. Paul and Dr. Bargar receive the Joseph F. Engenberger Award.
ISS company goes public (NASDAQ, Small Cap Market).
ISS sells 2 ROBODOC systems to Austria.
ORTHODOC Pre-operative Planning software, receives FDA approval.
Dr. Lee's hospital in S. Korea purchases a ROBODOC system, the first in Korea. With this system, Dr. Lee's hospital becomes one of the five leading joint replacement surgery hospitals in Korea.
Kangdong Catholic Hospital in Korea purchases a ROBODOC system.
ISS operational hiatus period (due to lack of operating capital)
Choennam University, Kyeoung Hee University, Ulsan Hospital, (all in S. Korea), purchase ROBODOC systems.
Curexo Inc. purchases all ISS assets.
Curexo Inc. establishes CTC (Curexo Technology Corporation) and transfers all ROBODOC assets, including IP and technology, and retains major shareholder position. CTC begins re-hiring previous key ISS employees. CTC submits ROBODOC system for FDA 510(k) approval.
CTC receives $12M (USD) additional funds to continue operation.
FDA approves ROBODOC THA systems for U.S. sales under 510(k) rules.
Curexo and IBM enter into a major patent Cross licensing agreement.
Curexo receives the NSAI Certificate of Registration of Quality Management System to I.S. EN ISO 13485:2003
Curexo raises $13.2 million of funding.
More history of the ROBODOC at Curexo's website.
Source: Curexo

Saturday, August 6, 2011

No-scar surgery with the MASTER robot

Please welcome the first guest-editor of the blog: Kurt Sun Zhenglong, PhD candidate at Nanyang Technological University's BioRobotics lab.

The MASTER system has been under development for over 6 years, and now it's in the clinics. See the video coverage of the first trial here. (An earlier paper and a presentation on the sytem here.)
Flexible endoscopes can be used to inspect, diagnose and treat various pathologies in the upper or lower gastro intestinal (GI) tract. A typical endoscope includes an ultra compact Charged-Coupled Device (CCD) camera, light source and a channel for infusing or withdrawing liquid or gas from the patient’s body. The tip of the endoscope is steerable so that the endoscope is able to transverse through the winding channel of the GI tract faster, safer and giving less pain to the patient. The endoscope also provides tool channels for instruments to go through which enable the endoscopist to perform a variety of treatments such as biopsy, polypectomy, marking, haemostasis, etc. Commercially available manually operated endoscopic tools often only provides for up to two Degrees of Freedom (DOF) for mostly grasping actions. This limited DOF still prevents state-of-the-art tools from performing complex tasks such as ESD (endoscopic submucosal dissection). The loss of depth perception, tactile and force sensations adds to the difficulty in performing dexterous maneuvers using a flexible endoscope.
The MASTER system has been developed by a research group lead by Associate Professor Louis Phee of Nanyang Technological University (NTU) and Professor Ho Khek Yu of National University Hospital (NUH), to tackle these problems. The system consists of a master console, a telesurgical workstation, and a slave manipulator which holds two end-effectors, a grasper and a monopolar electrocautery hook. With a total number of 9-DoFs in two robotic arms, the system enables the surgeon to perform complex surgical procedures which could hardly be achieved in a non-invasive manner. The system would be operated by an endoscopist and a surgeon. The former would traverse and maneuver the endoscope while the latter would sit in front of the master console to control the slave manipulators.
Recently, using this technology, surgeons at AIG, Hyderabad, India, have successfully performed tumor removal for 3 patients suffering from gastric cancer, which is possibly the world-first to be performed on stomach cancer patients—said Singapore doctors.  It cuts surgery time for stomach cancer patients to 17 minutes from eight hours, does reduces the length of hospitalization, and allows patients to undergo surgery without having to bear scars.
Associate Professor Louis Phee, head of the Division of Mechatronics and Design at NTU, said: "With this robotic system, you're giving a lot of maneuverability and dexterity to the endoscopist such that he can act and perform like a surgeon. It becomes possible to manipulate tissues, to cut and in the near future, to suture wounds inside the stomach."
While the gadget has reaped benefits during its trial stages, experts say there is still room for fine-tuning. Professor Ho Khek Yu, senior consultant at the Department of Gastroenterology and Hepatology at NUH, said: "Currently, we can only do procedures on early stomach tumors because the robotic arms are fashioned to do this procedure only. This procedure is challenging and needs a certain period of training. We need to adapt the robotic arms further to allow us to do more complicated procedures such as obesity surgery and anti-reflux surgery in future."
By Kurt Sun Zhenglong

Read about it on MedGadget as well, and on their research page.