Simbionix Revolutionary Patient Specific Simulation PROcedure Rehersal Studio™ Receives First of Its Kind US Patent

Cleveland, OH: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training, has been granted a US patent for its patient specific simulation product, thePROcedure Rehearsal Studio™ (PRS). This follows a similar patent granted in the United Kingdom and is the first such patent ever granted in the United States.

The PROcedure Rehearsal Studio is a first in industry product, which utilizes revolutionary technology, developed by Simbionix, to allow physicians to rehearse a complete endovascular procedure on a virtual 3D anatomical model based on a specific patient’s CT data. The virtual model may then be used for the purpose of simulating, analyzing and evaluating preoperative surgical treatment options prior to performing the actual procedure, which may increase physician’s confidence in the upcoming procedure. Once the 3D model has been exported to the Simbionix ANGIO Mentor™ simulation environment, the physician can practice numerous times to evaluate different techniques, while using true-to-life tools and endografts.

The patent was granted on Simbionix’s concept and proprietary core technology used in order to simulate an image guided angioplasty procedure based on input from a patient’s 3D medical image, allowing a hands-on planning and rehearsal experience. Unique to Simbionix simulation systems, the 3D segmentation model can be exported to the Simbionix ANGIO Mentor practice environment. The results are an advanced method of creating an ever expanding library of unique clinical case studies for training and post-operative debriefing. The patent also covers various broad uses for the technology including use in DICOM format, use of 4D data, use as a study case (i.e. post-operative use), demonstration of a planned procedure to a patient etc.

Mr. Boaz Tal, Simbionix CFO added that “With this key patent and three FDA 510(k) clearances granted for the PROcedure Rehearsal Studio applications (Carotid, EVAR and TEVAR), Simbionix once again demonstrates its key position as a market leader and innovator in the field of medical simulation. Having been granted the patent is an additional sign of recognition for the Simbionix comprehensive line of products, which provide innovative solutions to enhance clinical performance and advance patient safety.”

Third FDA Clearance for Revolutionary Simbionix Product

Simbionix USA Corporation, the world’s leading provider of medical education and simulation training, has received FDA clearance for its TEVAR (Thoracic Endovascular Aneurysm Repair) application forPROcedure Rehearsal Studio™ (PRS). This application joins the family of PRS cleared for marketing applications for Carotid Intervention and EVAR (Endovascular Aneurysm Repair) procedures.

TEVAR is an emerging treatment modality, which has been rapidly embraced by clinicians treating thoracic aortic disease. It is a far less invasive approach than open surgery. Additionally, the availability and relative ease of application with TEVAR has changed and extended management options in thoracic aortic disease, including in patients deemed unsuitable for open surgery. The skills necessary to perform TEVAR require dedicated formal training, as this procedure requires considerable perceptual, cognitive and psychomotor demands on the surgeons.

The PROcedure Rehearsal Studio utilizes revolutionary technology, developed by Simbionix, allowing physicians to rehearse a complete endovascular procedure on a virtual 3D anatomical model based on a specific patient’s CT data. The virtual model may then be used for the purpose of simulating, analyzing and evaluating preoperative surgical treatment options prior to performing the actual procedure, which may increase physician’s confidence in the upcoming procedure. Once the 3D model has been exported to the Simbionix ANGIO MentorTM simulation environment, the physician can practice numerous times to evaluate different techniques, while using true-to-life tools and endografts.

The Society of Vascular Surgery suggests that surgeons perform a minimum of 100 diagnostic, 50 interventional and 10 TEVAR cases to become certified. With this new innovative application, physicians can actually receive hands-on training in TEVAR procedures, including precise deployment of single and multiple stent grafts, as well as touch-up ballooning, before operating on a live patient. The PRS simplifies procedure planning, and provides a comprehensive solution for training and simulation of patient specific procedures aimed to enhance the professional level of both experienced and novice physicians.

According to Dr. Yael Friedman, Director of Regulatory Affairs for Simbionix, the Simbionix track record in providing healthcare professionals with innovative simulation tools is the foundation of yet another successful product. “Thoracic Endovascular Aneurysm Repair is one of the most advanced medical procedures that endovascular surgeons perform. Simbionix is extremely pleased to have received the FDA clearance and proud of our new PROcedure Rehearsal Studio clinical TEVAR application which will help clinicians in analyzing and evaluating preoperative surgical treatment options.”

Valencia College Utilizes Sophisticated Simbionix Simulators in Their Cardiovascular Technology (CVT) Training Program

Cleveland, OH:  Simbionix provides Cardiovascular Technology (CVT) programs with training simulators that deliver a virtual reality experience for their students.  Valencia College in Orlando, FL, utilizes this technology in their Allied Health Department’s CVT program.

Community college educators use Simbionix simulators to provide hands-on experience for their students in cardiovascular and peripheral vascular training. Some of the modules on the ANGIO Mentor include Coronary, CRM (Cardiac Rhythm Management), Renal, SFA, Iliac, and BTK (Below-the-Knee).

“Ultimately, the use of simulation in the Health Science programs at Valencia is critical to the student’s training, said Penny Conners, Dean of Allied Health, Valencia College.  “In our cardiovascular technology program, with the aid of the Simbionix simulator, our students are able to replicate the exact procedures that they will be performing in the hospital setting. In this regard simulation helps the students to understand and put safety first for the patients so they can give the best care possible while working in their field.”

The ANGIO Mentor provides experience with basic/advanced guidewire and catheter skills, familiarity with endovascular procedures, cath lab team experience.  Other skills include how to operate the C-arm, patient’s table, fluoroscopic screen, as well as how to read the hemodynamic monitoring and administer medications due to complicated treatment.  The simulator offers hands-on training that is designed to enhance manual dexterity and improve appropriate instrument decision making.  Students feel the high-end haptic that provide realistic simulation of guidewire, balloon, stent and other interventional devices.

“The ANGIO Mentor has been widely embraced by medical colleges in the education of surgical residents and fellows,” said Inbal Mazor, VP of Marketing for Simbionix. “Now, our portable haptic simulators and vast library of modules and cases have been embraced by community college CVT programs.”

Team training exercises build confidence and help students understand the requirements of all of medical team members.  Patient safety is the primary focus of the vast curricula and validation studies have reinforced the value of simulators in professional development.

Arthroscopy Training Now Better Than Ever With the Simbionix ARTHRO Mentor™ Including MentorLearn™ and Improved Hardware

Modifications intended to increase the ARTHRO Mentor’s performance and enhance user experience.

Simbionix Announces License Agreement for Surgical Videos

Cleveland, OH:  Simbionix USA Corporation, the world’s leading provider of medical simulators and education solutions, is pleased to announce an agreement with Duke University to license surgical videos and other instructional materials.  These resources were developed by Duke physicians and they cover the advanced skills and procedures addressed in Phase 2 of the ACS/APDS Surgical Skills Curriculum for Residents.

Simbionix will make these materials available at no cost to the users of its MentorLearn system as part of the implementation of the ACS/APDS Surgical Skills Curriculum for Residents. MentorLearn is a web-based simulator curricula management system that provides the optimal solution for managing training and education needs for the Simbionix line of simulators.

The main strength of MentorLearn is the incorporation of didactic materials with skills training.  The surgical videos and materials from Duke and other leading institutions are coupled with the complete procedures in the Simbionix simulators.  This is a powerful combination for learners who can see an actual surgery, followed by conducting the same procedure in a simulated environment.

“The Simbionix collaboration with Duke University’s Department of Surgery will give surgeons-in-training around-the-world exposure to the techniques and case management practices from experienced surgeons to whom they wouldn’t routinely have had access,” said Paul Jensen, Simbionix General Manager, Education Division.

“By providing a link between simulated learning and real-world cases, we hope to enhance the value of our training curriculum to our residents,” said Philip Clark, Education Director at Duke University, Department of Surgery

“The real case footage we are creating with Duke will improve resident’s cognitive understanding of surgical procedures,” said Jensen. “Coupling the insight of Duke’s surgeons with Simbionix’ hands-on simulators will improve training efficiency and allow trainees to reach proficiency sooner.”

About Duke University:

Duke University is a nonprofit educational, research and healthcare institution located in Durham, North Carolina.

Simbionix Signs an Agreement with the Laparoscopic Surgical Skills Foundation (LSS)

Cleveland, OH:  Simbionix and the Laparoscopic Surgical Skills Foundation (LSS) signed a collaboration agreement that is supported by Europe’s most prestigious society in the laparoscopic discipline, The European Association for Endoscopic Surgery (EAES).  Training materials and assessment tools for the European Laparoscopic Skills Curriculum will be the result of this initiative.

Recent safety and surgical quality performance reports from the World Health Organization and others stress the urgent need for the improvement of training, assessment, and accreditation for technology-dependent surgical procedures such as laparoscopy. LSS is an initiative by the European Association for Endoscopic Surgery (EAES) to provide a standard to (re)credential surgeons to perform laparoscopic surgery effectively and safely. LSS goes beyond the basic skills and focuses on safeguarding the quality of performance in laparoscopic procedures.

This agreement is a continuation of successful two-year collaboration during which the LSS program has been operating in training centers across Europe.  This incorporates the Simbionix LAP Mentor in the process of defining and validating the criterion-based assessment tool and clinical assessment of index procedures performance.

Professor Jakimowicz, MD, PhD, FRCS Ed said, “This agreement shows the benefit of industry and professional society collaboration. The structure of the training, applicability of the course content in practice and the proportion of theory and hands-on training are rated positively by the trainees.”  Prof. Jakimowicz added, “The LSS program appeals to both residents in training and already accredited surgeons. International participation indicates that the LSS program has the potential to become a future European standard in surgical education in laparoscopic surgery. “

Ran Bronstein, President of Simbionix, expressed excitement about the agreement: “As a leading provider of medical simulators and online medical education, Simbionix understands the importance of providing access to standardized training. This collaboration, by leveraging the clinical knowledge and experience of the EAES and the innovative technologies of Simbionix, will set a new standard for laparoscopic skills training in Europe.”

About the LSS:
Laparoscopic Surgical Skills (LSS) program, developed under the auspices of the European Association for Endoscopic Surgery (EAES), aims to provide a standard to credential surgeons to perform laparoscopic surgery effectively and safely.

Presenting The First Ever Hands On Skills Assessments Examination for Endoscopy Certification

Cleveland, OH: Traditionally, the only way to assess technical skills in the medical field has been through unstructured, subjective observation. Therefore, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Fundamentals of Endoscopic SurgeryTM (FESTM) program has taken a giant step toward more reliable and valid measures of surgical performance to improve patient safety. As part of this initiative, SAGES together with Simbionix™, a leader in surgical simulation, have developed the first ever virtual reality system that can objectively assess surgical endoscopic skills.

The FES program is a comprehensive educational module and assessment tool designed to teach and test the fundamental knowledge, clinical judgment and technical skills required in the performance of basic gastrointestinal (GI) endoscopic surgery (endoscopy). FES intends to set a validated benchmark of understanding and necessary skills in basic endoscopy in order to improve the quality of patient care.

The Simbionix GI Mentor™ is a top–of-the-line endoscopic medical simulator for the training of gastrointestinal upper and lower endoscopic procedures. The simulator provides multiple training opportunities with true-to-life patient cases offering realistic scenarios of clinical situations using customized actual tools. The GI Mentor provides a comprehensive environment for practicing clinical procedures in a safe and realistic manner.

The FES test measures cognitive knowledge and judgment, and uses the GI Mentor virtual reality platform to evaluate fundamental technical skills. The educational module consists of a web-based multimedia presentation of didactic content. Those who successfully complete both the educational and assessment components will have demonstrated the basic knowledge, judgment and technical skills fundamental to the performance of endoscopic surgery.

After long development and validation of the module using the Simbionix GI Mentor, the SAGES FES exams will be officially up and running in Spring 2013. Medical professionals taking this test will be objectively assessed, with tests sites being restricted to general surgery residency programs in the US and Canada. Among the first test center sites are University Hospitals- Case Medical Center, Cleveland, Ohio; The Methodist Hospital, Houston, Texas; and McGill University Health Centre, Montreal, Quebec.

To experience the realistic virtual reality hands-on training available on the GI Mentor, visit Simbionix booth #609 at IMSH, January 27-29 in Orlando, FL.

SAGES is a not-for-profit professional membership organization which represents a worldwide community of surgeons that bring minimal access surgery, endoscopy and emerging techniques to patients in every country. Representing over 6,000 surgeons and allied health professionals, their mission is to provide leadership in surgery, particularly gastrointestinal and endoscopic surgery, in order to optimize patient care through education, research and innovation.

Live Case at TCT Mirrors PRS Patient Specific Simulation Rehearsal

Cleveland, OH:  The Simbionix PROcedure Rehearsal Studio™ (PRS) was put to the test when Barry T. Katzen, MD, FACR, FACC, FSIR, Founder/ Medical Director of Baptist Cardiac and Vascular Institute utilized the technology to pre-operatively plan and rehearse for a Live Case he performed at the 2012 TCT Conference.  Following the rehearsal done in advance of the surgery, Dr. Katzen performed the EVAR endovascular intervention live at the TCT.  This “Future Techniques for Endovascular Therapy” session demonstrated new techniques for possible improvements on a variety of procedures in the endovascular space.

The practice session involved the pre-operative review of the  patient’s anatomy, selection of tools dedicated for EVAR procedure, including deploying a Gore C3 Excluder endoprosthesis .The patient had challenging anatomy with a lot of iliactortuosity and a fairly big flow lumen which posed technical challenges for the group of physicians doing this procedure.

The patient’s CT scan was downloaded into the PRS which allowed Dr. Katzen to create a patient-specific 3D virtual anatomical model.  Dr. Katzen used it to plan and practice the endovascular intervention which included the identification of the appropriate access strategy, selection of tools, guide wires, catheters, endoprosthesis as well as choosing the effective fluoroscopic views.

At TCT, Dr. Katzen showed the practice video and then performed the actual surgery on the patient they had rehearsed earlier. The live case replicated the rehearsal.

“The patient presented several anatomic challenges that were realistically demonstrated in the simulator,” said Dr. Katzen.

“As a result of the PRS simulation, we reevaluated our measurements and modified the right side of the limb.  We verified, went back and recalculated everything and basically adjusted the right limb size. We felt that it was going to work and it did,” said Dr. Katzen. “The simulation has predicted type Ib endoleak in the right limb which we actually corrected with a balloon and didn’t have to put in another graft.”

“I find the rehearsing part of the simulation incredibly interesting,” said Dr. Katzen.  “This will be great for a surgeon or an Interventionalist because it is all about better outcomes.”

Innovative Simulation Solutions Change Surgical Education- Simbionix Launches Four New Products At ACS

Cleveland, OH: Simbionix USA Corporation, a world leader of medical simulation training and education products, will introduce a record number of new products at the upcoming American College of Surgeons Exhibition, including the MentorLearn™ Online solution for both the LAP Mentor™ and the GI-BRONCH Mentor™, the new LAP Mentor™ Appendectomy Module, the Suturing Module for the da Vinci®Si™ Skills Simulator and a Suggested Implementation of the ACS/APDS Surgical Skills Curriculum.

MentorLearn, the company’s web based Simulator Management System, provides the optimal solution for managing training and education needs for the Simbionix line of simulators. Being available on both the LAP Mentor and the GI-BRONCH Mentor allows training centers the opportunity to incorporate multi-disciplinary simulators into the residency curriculum, and provide documentation of training for accreditation and certification – which is the ideal solution for the ACGME requirement for simulation based training.

The LAP Mentor Appendectomy Complete Procedure Module provides training for the skills and knowledge of key components of the Appendectomy procedure. The module enables practicing a variety of techniques and appropriate use of surgical instruments. An anatomical 3D map, real-life videos, interactive 3D guidance and comprehensive objective performance metrics enrich and enhance the learning experience.

Simbionix has partnered with Intuitive Surgical® to develop the Simbionix Suturing Module for virtual reality simulation of suturing on the Skills Simulator™ for the da Vinci®Si™ System.

This module is a continuation of Simbionix’s effort to provide highly realistic and effective tools designed for cost-effective integration in surgical curricula across multiple disciplines and technologies.

The new LAP Mentor curriculum deployed on the MentorLearn application- “Simbionix Suggested Implementation of the ACS/APDS Surgical Skills Curriculum for Residents, Phase 2: Advanced Procedures”, adheres to the objectives outlined by ACS/APDS and their corresponding training modules, incorporating Simbionix complete procedure simulation within the modules where applicable, and premium video based educational content.

Gary Zamler, Simbionix CEO, commented: “I am proud to work in a company that has maintained its mission as stated when established, to continuously create partnerships and products to provide the most advanced tools in the market. Our close collaboration with the surgical community is one of our building blocks, assisting us in our ongoing process of enhancing our simulators by adding training modules to both our systems and to additional surgical solutions created by others,  and expanding learning opportunities and learning processes. Our goal is to provide medical education programs and accrediting bodies with flexible yet complete training tools.”

Stop by Simbionix booth #2026 at ACS, October 1-3, in Chicago, IL, for a hands-on experience of the LAP Mentor, LAP Mentor Express, GI-BRONCH Mentor and recently introduced GI Express, alongside our new products.

Simbionix Releases Lower Limb Training Module for the ANGIO Mentor™ Endovascular Simulator

Cleveland, OH: Simbionix USA Corporation, the world’s leading provider of medical simulation, training and education products, announces increasing its library of training opportunities on the ANGIO Mentorwith the new Below-The-Knee (BTK) module.

The Simbionix ANGIO Mentor products are multidisciplinary surgical simulators that provide hands-on practice of endovascular procedures in a virtual reality simulated environment.

Lower-limb ischemia, a Peripheral Arterial Disease (PAD), is a vascular disorder which occurs when oxygen supply to the leg tissues is reduced due to poor blood flow caused by atherosclerosis.

Patients with Critical Limb Ischemia present with rest pain, which may progress to ulceration and gangrene, experience high amputation rates, significant morbidity and cardiovascular events. Undergoing endovascular below-the-knee revascularization may increase the possibility of saving the limb. Still, Critical Limb Ischemia is associated with multi-segmental complex arterial lesions, which contribute to the challenge of these procedures. Developments in medical devices and recent advancement in techniques help surgeons overcome these procedural challenges.  The Simbionix BTK simulation module helps surgeons build confidence with the clinical and practical aspects of BTK Interventions using the latest techniques and therapeutic approaches available.

The module was developed in collaboration with leading worldwide physicians, including Dr. Andrej Schmidt from the Center for Vascular Medicine, Parkhospital andHeartcenter Leipzig, Germany. “The role of endovascular therapy for patients with critical limb ischemia is steadily increasing. Therefore skills to treat infrapopliteal arteries is extremely important, which are clearly completely different to treat than iliac or femoropopliteal lesions. Simbionix module for BTK interventions is, in our opinion, a very important learning-tool and perfectly brought into praxis.”

“The ANGIO Mentor provides a complete training solution to learners of all levels and across multiple disciplines”, said Gary Zamler, Simbionix CEO. “The new BTK module was very well received by doctors of all skills levels, who all commented on the high realism of the simulated procedure in comparison to other available products. The ANGIO Mentor’s true value lies within its vast training opportunities. As we strive to offer our customers the best ROI, we continuously develop new modules for this robust simulator to answer the needs of endovascular surgeons.”

To experience the ANGIO Mentor hands-on, visit Simbionix at the training sessions at SVS, June 6-8, in National Harbor, MD.