SafeOp Surgical, Inc
SafeOp Surgical, Inc

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SafeOp Surgical Files for 10th Patent Extending Capabilities of its EPAD Intraoperative Neuromonitoring Platform
7-11-17 6:00 AM EDT

 

 

 

 

 

 

 

 Latest innovation rapidly detects responses that identify proximity and health of nearby nerves

 

HUNT VALLEY, Md.--()--SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its tenth patent application for innovations surrounding the monitoring and real-time detection of motor nerve thresholds during surgery. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring platform that enables the detection of nerve damage and post-operative residual paralysis during surgical procedures. This latest filing is for the added capability to stimulate nerves during surgery to rapidly detect responses that help the surgical team identify the proximity and health of nearby nerves. SafeOp already holds or has provisional patents for detection of peripheral nerve injury using somatosensory evoked potentials, as well as signal processing and high specificity in alerting to signal change, and on neuromuscular junction testing and spinal cord stimulator paddle placement in one or more of the United States, European Union, Australia, Japan and China.

 

“Detecting the proximity of nerves, including whether surgical instruments may have breached bones that are close to nerves, is essential in avoiding inadvertent nerve injury during surgery. Injuries such as those to the femoral nerve, which controls the ability to extend a leg, can be devastating,” said Richard O’Brien, MD, MBA, SafeOp’s vice president of development and chief medical officer. “While other techniques exist for detecting nerve proximity during some surgeries, this new capability has the advantage of partially accounting for the presence of paralytic agents that can interfere with testing while still maintaining speed. This makes the likelihood of false negative responses less likely.”

 

SafeOp’s EPAD™ system platform currently allows monitoring of both the spinal cord and peripheral nerves. It was developed specifically for the rapid detection of perioperative nerve injury (“PNI”). PNI is a frequent complication of some surgeries (such as orthopedic, general, cardiac, or urological), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use quantitative monitoring of the neuromuscular junction to help detect another frequent complication, post-operative residual paralysis. This may occur when paralyzing agents have not sufficiently worn off at the end of surgery. The EPAD™ system provides real-time feedback, allowing caregivers to adjust the patient’s position or surgical technique in time to avoid nerve injury, or to intervene when residual paralysis is present.

 

“This latest patent filing is another example of the powerful capabilities of the EPAD™ system platform. We expect this new capability to allow utilization of the EPAD™ in surgeries such as the lateral approach, a type of spine surgery, and other standard spine surgeries that can benefit from motor nerve mapping technology,” said Gene Cattarina, SafeOp’s president and chief executive officer. “In addition to this patent filing, we anticipate releasing EPAD’s electromyography (EMG) capability in the first quarter of 2018.”

 

About SafeOp Surgical, Inc. 
SafeOp Surgical, Inc. is a Hunt Valley, Maryland-based medical device company that has developed the FDA-approved EPAD™ system. The robust EPAD™ system platform enables simple-to-use, cost-effective neurological monitoring in a wide array of surgical procedures. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit SafeOp’s website at www.safeopsurgical.com.

 

 

 

SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Cell: 214-213-9379
cbrown@safeopsurgical.com

 

SafeOp Surgical Files for Ninth Patent

Latest EPAD™ System innovation reduces false positive alerts during surgical nerve monitoring

 

HUNT VALLEY, Md.--()--SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its ninth patent application for innovations surrounding the monitoring of somatosensory-evoked potentials during surgeries. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring system that enables the detection of nerve damage and post-operative residual paralysis during surgical procedures. This latest filing is for the capability to reduce false positive alerts to nerve damage during surgeries. The company already holds patents for detection of nerve injury in the United States, Australia, Japan and China, and has several patents pending that include signal processing and high specificity in alerting to signal change, and on neuromuscular junction testing and spinal cord stimulator paddle placement.

 

“Electrical noise from nearby equipment often causes false alerts that are time consuming to deal with,” said Richard O’Brien, MD, MBA, SafeOp’s vice president of development and chief medical officer. “This new patent provides a method to condition the monitored responses and calculate an alert so that the likelihood of a false positive from a noisy signal is dramatically reduced while preserving the sensitivity of the monitoring to real changes.”   
 

SafeOp’s EPAD™ system, which allows monitoring of both the spinal cord and peripheral nerves, was developed specifically for the rapid detection of perioperative nerve injury (“PNI”). PNI is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use quantitative monitoring of the neuromuscular junction to help detect another frequent complication, post-operative residual paralysis. This may occur when paralyzing agents have not sufficiently worn off at the end of surgery. The EPAD™ system provides real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury, or intervene when residual paralysis is present.

 

“We continue to innovate our EPAD™ system technology with powerful capabilities that will make it the most cost-effective intraoperative monitoring solution available,” said Gene Cattarina, SafeOp’s president and chief executive officer. “With its unique ability to economically and efficiently acquire somatosensory-evoked potentials, the EPAD™ is appropriate for all types of surgeries and an ideal low cost alternative to expensive insourced- and outsourced-driven neuromonitoring for certain spine and other surgeries.”

 

About SafeOp Surgical, Inc.

SafeOp Surgical, Inc. is a Hunt Valley, MD-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables simple-to-use neurological monitoring in a wide array of surgical procedures where full monitoring – which requires the continuous presence of a technologist and neurologist – may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit SafeOp’s website at www.safeopsurgical.com.

 

Contacts

SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Cell: 214-213-9379
cbrown@safeopsurgical.com


SOTA Medical Products and SafeOp Surgical Ink Distribution Agreement

January 25, 2017 06:00 AM Eastern Standard Time - Leading medical technology distributor to market SafeOp’s revolutionary EPAD™ neuromonitoring system
 

CEDAR GROVE, N.J.–(BUSINESS WIRE)–State of the Art Medical Products, Inc. (“SOTA”) today announced that it has signed a three-year distribution agreement with SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company. Under the terms of the agreement, SOTA will have the exclusive rights to distribute SafeOp’s EPAD™ portable neuromonitoring system to healthcare facilities in the New York Metropolitan area (Hudson Valley, New York City and Long Island), New Jersey, Connecticut, Delaware and Pennsylvania. The EPAD™ system enables the detection of nerve damage and residual paralysis during surgical procedures.

“For over 30 years, SOTA has been bringing to our customers cutting-edge technology products that can provide both better patient care and a financial advantage,” said Keith Lambie, president and founder of SOTA. “SafeOp’s EPAD™ system is just such a revolutionary product with its ability to deliver a new and needed level of patient safety to surgeries where such monitoring had not been cost-effective. As with all the products we represent, we’ve done our homework. We anticipate great success in selling EPAD™.”

SafeOp’s EPAD™ system was developed particularly for the rapid detection of Positioning Effect (“PE”). PE is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use monitoring of the neuromuscular junction to help detect residual paralysis, which may occur when paralyzing agents have not sufficiently worn off at the end of surgery. It offers real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury or to intervene when residual paralysis is present.

“This relationship is a key step in bringing to market our unique, cost-effective alternative to expensive insourced- and outsourced-driven neuromonitoring for certain spine surgeries,” said Gene Cattarina, SafeOp president and chief executive officer. “We’re delighted to have entered into this agreement with SOTA, an organization with an uncanny knack for identifying and successfully marketing new medical technologies. They are an ideal fit to distribute the EPAD™ system in one of the most concentrated hospital markets in the country.”

About State of the Art Medical Products, Inc.
State of the Art Medical Products, Inc. (SOTA) is a specialty medical sales and distribution company. SOTA’s sales territory includes the New York Metropolitan area (Hudson Valley, New York City and Long Island), New Jersey, Connecticut, Delaware and Pennsylvania. SOTA’s management team has over 75 years of management, sales and clinical experience. To properly support its manufacturers and its customers, SOTA has evolved into three separate sales teams servicing three specific markets: Advanced Surgical Technologies, Cardiovascular / Interventional Radiology and Surgical. Supporting the sales team is an in-house staff located in Cedar Grove, New Jersey. Visit SOTA’s website at www.sotamedical.com.

About SafeOp Surgical, Inc.
SafeOp Surgical, Inc. is a Hunt Valley, Maryland-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables basic neurological monitoring in a wide array of surgical procedures where full monitoring, which requires the continuous presence of a technologist and neurologist, may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit the SafeOp website at www.safeopsurgical.com.

Contacts

State of the Art Medical Products
Keith Lambie, 800-321-7682
973-571-2400
President
KLambie@sotamedical.com
or
SafeOp Surgical
Chris Brown, 410-773-9601
Cell: 214-213-9379
Vice President of Sales
cbrown@safeopsurgical.com


Abrazo Arizona Heart Hospital Selects SafeOp Neuromonitoring Technology Facility to implement innovative EPAD™ system for patient safety during surgery

Hunt Valley, MD, August 9, 2016 –  SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced an agreement with Abrazo Arizona Heart Hospital (“AAHH”), Phoenix, AZ.   AAHH will begin using SafeOp’s EPAD™ portable neuromonitoring system for the detection of nerve damage during surgical procedures.

SafeOp’s goal is to enable simplified neurological monitoring in a wide array of surgical procedures where more complex and expensive monitoring may not be indicated, cost-effective or feasible. The EPAD™ system was developed particularly for the rapid detection of Positioning Effect (“PE”).  PE is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. Additionally, the EPAD system allows easy-to-use monitoring of the neuromuscular junction to aid in detection of residual paralysis, which may occur when paralyzing agents have not sufficiently worn off at the end of surgery. EPAD offers real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury or intervene when residual paralysis is present.

“SafeOp Surgical is pleased to have Abrazo Arizona Heart Hospital as our first customer in Arizona,” said Gene Cattarina, SafeOp’s president and chief executive officer. “We look forward to supporting and contributing to Abrazo’s commitment to excellence in patient care.”

ABOUT SAFEOP SURGICAL, INC.

SafeOp Surgical, Inc. is a Hunt Valley, MD-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables basic neurological monitoring in a wide array of surgical procedures where full monitoring, which requires the continuous presence of a technologist and neurologist, may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers in the United States. For more information, visit http://safeopsurgical.com.

Media Contact
Chris Brown
Vice President, Sales and Marketing
410.773.9601
cbrown@safeopsurgical.com


SafeOp Surgical, Inc. Names Gene Cattarina CEO

 

May 04, 2016 01:34 PM Eastern Daylight Time - HUNT VALLEY, Md.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that industry veteran Gene Cattarina will join SafeOp as chief executive officer. Mr. Cattarina, who will also serve as a board member, brings over 40 years of experience in numerous senior executive positions at companies in healthcare information systems, products, medical devices and professional services.“With the full management team onboard, SafeOp is now well positioned to aggressively bring the EPAD™ system to market”

Most recently, Mr. Cattarina was president and CEO of Capsule Technologie, Inc., a leading global provider of medical device integration solutions to hospitals and healthcare systems. Capsule was recently sold to Qualcomm, Inc. (NASDAQ:QCOM). Prior to Capsule, Mr. Cattarina served as president and CEO of Impulse Monitoring, Inc., a provider of intraoperative neurophysiological monitoring solutions. He has also held executive leadership positions at Lynx Medical Systems, Inc., now a part of Optum®; Landacorp, Inc.; Medicode, Inc., also now a part of Optum®; and TDS Healthcare Systems, now a part of Allscripts.

“With the full management team onboard, SafeOp is now well positioned to aggressively bring the EPAD™ system to market,” said Mr. Cattarina. “I’m looking forward to being reunited with members of our Impulse Monitoring team who have developed the EPAD™ system. It’s a truly unique product that I believe will make a major contribution towards improving surgical outcomes.”

SafeOp’s goal is to enable simplified neurological monitoring in a wide array of surgical procedures where more complex and expensive monitoring may not be indicated, cost-effective or feasible. The EPAD™ system was developed particularly for the rapid detection of Positioning Effect (“PE”). PE is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. Additionally, the EPAD™ system allows easy-to-use monitoring of the neuromuscular junction to aid in detection of residual paralysis, which may occur when paralyzing agents have not sufficiently worn off at the end of surgery. It offers real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury or intervene when residual paralysis is present.

About SafeOp Surgical, Inc.

SafeOp Surgical, Inc. is a Hunt Valley, Maryland-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables basic neurological monitoring in a wide array of surgical procedures where full monitoring, which requires the continuous presence of a technologist and neurologist, may not be indicated, cost effective or feasible. SafeOp currently markets the EPAD™ system to medical centers in the United States. For more information, visit the SafeOp website at http://safeopsurgical.com.

Contacts
SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Vice President, Sales and Marketing
cbrown@safeopsurgical.com


SafeOp Surgical Receives FDA Clearance for EPAD™ Neuromonitoring Device

 February 26, 2014 07:00 AM Eastern Standard Time - GREENWICH, Conn.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”) has received FDA clearance to market its Evoked Potential Assessment Device (EPAD™). The device is portable and intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEPs) or assessing the neuromuscular junction (NMJ).

SafeOp’s goal is to enable basic neurological monitoring in a wide array of surgical procedures where full monitoring, which requires the continuous presence of a technologist and neurologist, may not be indicated, cost effective or feasible. The FDA-cleared EPAD™ utilizes proprietary algorithms, electrodes, and cables, along with Bluetooth technology to allow easy set-up and integration into current operating room practices.

“We are excited to bring neurological monitoring to a greater population of surgical patients in the U.S. market,” said Curt LaBelle, MD, MBA, president of SafeOp. “Just as cardiac function and respiratory function are monitored in surgical procedures, we believe that nerve function monitoring will become standard of care in the future, resulting in fewer adverse events for patients.”

SafeOp’s system records SSEPs, which are particularly effective in revealing positioning effect, which refers to damage to peripheral nerves during surgery that is caused by the way the patient is positioned on the surgical table. Certain positions compress or stretch peripheral nerves, or cause compromised blood supply to the nerves, all of which can lead to damage if the patient’s position is uncorrected. An everyday example of positioning effect is when a person wakes from sleep with an arm that is “dead” or “asleep.” The sleeping brain notifies the person to wake up and move or roll over to adjust position, which avoids nerve damage and quickly restores function. When under anesthesia, however, the patient can’t wake up and roll over, and thus nerve impairment can continue and lead to permanent injury.

SafeOp’s device has a feature that flags SSEP changes that are consistent with positioning effect. This allows caregivers to examine waveforms and decide if the early stages of positioning effect might be present and, if so, to adjust the patient’s position to avoid nerve injury. “Positioning effect is likely under-diagnosed and, despite caregivers’ best efforts, can occur in a significant number of surgeries. Until now it has often been considered a cost of doing surgery. As surgeries become longer and more complex, and utilize sophisticated technologies such as robotic assistance, a greater potential for positioning effect exists. Our system will proactively assist caregivers in deciding when to intervene and seeing if their intervention has made a difference. We also expect anesthesiologists to appreciate the EPAD™’s easy and accurate suite of protocols for one-touch assessment of the NMJ when using paralytic agents,” said Richard O’Brien, MD, FRCP(C), MBA, chief medical officer at SafeOp. “Where comprehensive neuro-monitoring with a technician and neurologist is not indicated, but positioning effect or paralytic effect remains an issue, our system adds vital information at minimal cost.”

SafeOp is currently introducing its device to a select number of centers, and will expand its commercial efforts in the second half of 2014. SafeOp is privately held and has been funded by Tullis Health Investors. For more information, please email info@safeopsurgical.com.

Contacts

Plum Hill Communications LLC
Melanie Johnson Oldeman, 978-302-0703
melanie@plumhillcom.com

 

Contact Us Today!

SafeOp Surgical Inc
11350 McCormick Rd. 

EP III, Suite 1003

Hunt Valley, MD 21031
Phone: 844-723-3677

E-mail: info@safeopsurgical.com

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