{"id":83562,"date":"2012-07-27T05:19:00","date_gmt":"2012-07-27T02:19:00","guid":{"rendered":"https:\/\/www.technion.ac.il\/blog\/fda-approved-corindus-making-heart-surgery-safer\/"},"modified":"2012-07-27T05:19:00","modified_gmt":"2012-07-27T02:19:00","slug":"fda-approved-corindus-making-heart-surgery-safer","status":"publish","type":"post","link":"https:\/\/www.technion.ac.il\/en\/blog\/fda-approved-corindus-making-heart-surgery-safer\/","title":{"rendered":"FDA Approved. Corindus – making heart surgery safer"},"content":{"rendered":"
FDA CLEARS FIRST ROBOTIC-ASSISTED SYSTEM FOR CORONARY ARTERY DISEASE STENT\u00a0<\/span>PROCEDURES<\/span><\/strong><\/p>\n\n\n\n\n
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Photos: Corindus<\/a>.
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\nCorindus Vascular Robotic<\/a>s wins 510(k) clearance for CorPath\u00ae 200 System; Robotic-assisted percutaneous\u00a0coronary interventions (PCI) enhances control and protects physicians from radiation<\/span><\/strong>
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\nNATICK, Mass. \u2013July 25, 2012 \u2013 Corindus Vascular Robotics, a leading developer of precision vascular\u00a0robotics, today announced FDA 510(k) clearance has been granted for the CorPath 200 System to be used in\u00a0<\/span>performing percutaneous coronary interventions (PCI). The technology is now approved in the United States to\u00a0<\/span>assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in\u00a0<\/span>patients with coronary artery disease (CAD).<\/span>
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\nCorindus was founded in 2000 by <\/span>Prof. Rafael Beyar<\/a>, the general director of Rambam Medical Center in Haifa. Its first CEO was\u00a0<\/span>Technion graduate<\/span>\u00a0Tal Wenderow, who had managed it since it was based at the Technion incubator. The company now operates in Massachusetts and is mainly run by a US team.<\/span>
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\nCorindus’s product enables doctors to carry out catheterization by full remote using a computer to control the robot’s arms. In this way, the doctor is not exposed to radiation caused by the need for X-ray imaging of the patient to see the location of the implant in the body. In addition, the surgeon is not bending over the patient, but comfortably sitting at a station. The chances of a catheterization doctor getting cancer are much higher than other doctors. Bending over a patient while keeping total concentration, while wearing a lead vest against radiation, causes severe back problems.<\/span>
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\n\u201cWe are pleased to have received clearance from the FDA for the world’s first system designed for roboticassisted\u00a0<\/span>PCI procedures,\u201d said David M. Handler, President and CEO of Corindus Vascular Robotics. \u201cThis is\u00a0<\/span>an important milestone for interventional cardiology as we take the next step in transforming the way these\u00a0<\/span>procedures are performed in the future. The CorPath System offers hospitals the opportunity to bring robotic assisted\u00a0<\/span>technology benefits to their coronary patients and their physicians.\u201d<\/span><\/p>\n

\u201cThe FDA clearance of the CorPath System will truly change the way I am able to practice. As interventional\u00a0cardiologists, we perform our procedures using X-ray guidance and are cognizant that throughout our careers,\u00a0<\/span>we will be exposed to a high amount of radiation. In the past, we have relied on heavy lead aprons to protect us\u00a0<\/span>from radiation, but the physical stress of wearing these aprons can lead to back pain, fatigue and orthopedic\u00a0<\/span>injuries,\u201d said Joseph P. Carrozza, Jr. M.D., Chief of Cardiovascular Medicine at St. Elizabeth\u2019s Medical Center\u00a0<\/span>in Boston. \u201cRobot-assisted PCI procedures allow us to provide our patients with the highest quality of care\u00a0<\/span>working in an ergonomic position with robotic-assisted stent and balloon placements to restore blood flow.\u201d<\/span><\/p>\n

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Recent data published in Catheterization and Cardiovascular Intervention journal demonstrated an\u00a0interventional cardiologist\u2019s daily exposure to radiation and the physical stresses inherent in the cath lab can\u00a0<\/span>lead to occupational health risks, including orthopedic problems, cataracts, and cancer. The CorPath PRECISE\u00a0<\/span>Trial\u2014a prospective, single-arm, multi-center, study, which served as the basis for the submission of a premarket\u00a0<\/span>clearance (510(k)) application to the FDA\u2014 demonstrated that robotically-assisted PCI is safe and\u00a0<\/span>feasible for patients. PCI was successfully completed without having to convert to manual PCI in 98.8 percent\u00a0<\/span>of patients and without device-related complications. The overall procedure success rate was 97.6 percent.<\/span>
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\nAdditionally, the trial found that robotic-assisted PCI can make the procedure safer for the interventional\u00a0<\/span>cardiologist by reducing the radiation exposure by 95 percent when performing the procedure with the CorPath\u00a0<\/span>200 System.<\/span><\/p>\n

\u201cGaining significant experience with the CorPath 200 System, I was impressed with its performance and the\u00a0precise control of the interventional devices, including manipulating the guidewire and stent and being able to\u00a0<\/span>move the devices precisely in increments as small as one millimeter,\u201d said Giora Weisz, M.D., Director of\u00a0<\/span>Clinical Research at the Center for Interventional Vascular Therapy at NewYork-Presbyterian\u00a0<\/span>Hospital\/Columbia University Medical Center and Associate Professor of Medicine at Columbia University\u00a0<\/span>College of Physicians and Surgeons, New York.<\/span><\/p>\n

\u201cWorking with this robotic technology is very intuitive and the\u00a0PRECISE trial demonstrated its applicability in today\u2019s cath lab environment. I strongly believe robotic-assisted\u00a0<\/span>PCI will enhance the way we are conducting PCI, and we are looking forward to adapting it in our everyday\u00a0<\/span>practice.\u201d<\/span><\/p>\n

The CorPath 200 System is the first and only robotic-assisted procedure to allow for controlled placement of\u00a0coronary guidewires and stent\/balloon catheters from an optimized interventional cockpit. The lead-lined\u00a0<\/span>cockpit protects the interventional cardiologist from harmful radiation exposure and the seated position in front\u00a0<\/span>of monitors may provide enhanced view of the angiography screen while reducing fatigue and minimizing head,\u00a0<\/span>neck and back strain.<\/span><\/p>\n

\u201cThere has been a tremendous amount of interest in the CorPath 200 System, and we are excited to bring to\u00a0market a solution that has the potential to transform the standard of care for PCI procedures,\u201d said Handler.\u00a0<\/span>\u201cCorindus is ready to help our customers successfully implement the complete CorPath-assisted procedure\u00a0<\/span>program into their institutions.\u201d<\/span><\/p>\n

About Corindus Vascular Robotics<\/strong><\/p>\n

Corindus Vascular Robotics (http:\/\/www.corindus.com) is the global technology leader in robotic-assisted\u00a0percutaneous coronary interventions. The Company\u2019s FDA cleared CorPath\u00ae 200 System is the first medical\u00a0<\/span>device that offers interventional cardiologists PCI procedure control from an interventional cockpit. The\u00a0<\/span>CorPath open-platform technology and intellectual property will enable Corindus to address other segments of\u00a0<\/span>the vascular market, including peripheral, neuro and structural heart applications.<\/span><\/p>\n

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Corindus Media Contacts:
\nCorindus Vascular Robotics Schwartz MSL
\nTal Wenderow Lloyd Benson\/Krystin Hayward
\n(508) 653-3335 ext. 205 (781) 684-0770
\ntal.wenderow@corindus.com corindus@schwartzmsl.com<\/div>\n
Corindus was formed out of Technion Patented innovation.\u00a0Search for new patents and innovation from Technion, Israel at <\/span>T3-Technion Technology Transfer.<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

FDA CLEARS FIRST ROBOTIC-ASSISTED SYSTEM FOR CORONARY ARTERY DISEASE STENT\u00a0PROCEDURES Photos: Corindus. Corindus Vascular Robotics wins 510(k) clearance for CorPath\u00ae 200 System; Robotic-assisted percutaneous\u00a0coronary interventions (PCI) enhances control and protects physicians from radiation NATICK, Mass. \u2013July 25, 2012 \u2013 Corindus Vascular Robotics, a leading developer of precision vascular\u00a0robotics, today announced FDA 510(k) clearance has been… Continue Reading FDA Approved. Corindus – making heart surgery safer<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[24],"tags":[],"class_list":["post-83562","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nFDA Approved. 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