New indication allows for the wide scale implementation to help protect children across the United States
Hampton, VA, January, 5, 2017 – Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age of 18. The device is a continuous monitor for a patient’s IV and provides early detection of an infiltration– when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs (PIVs) are one of the most common invasive medical procedures performed with over 150 million IV catheters placed in the Unites States annually, yet current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations. The ivWatch Model 400 was developed to address this unmet need in healthcare.
“We continue to focus on improving patient safety and outcomes,” states Dr. Brian Clare, Chief Medical Officer at ivWatch. “We are excited to be able to offer the ivWatch Model 400 for pediatric patients to enable children’s hospitals and other facilities catering to pediatrics another measure of protection for the early detection of IV infiltration or extravasation events.”
Pediatric patients can be at high risk for infiltrations due to body size and movement. With several hundred pediatric hospitals in the United States alone, the ivWatch Model 400 represents a new option for pediatric medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors while improving outcomes.
The ivWatch Model 400 received FDA clearance for patients 18 years and older in February 2015 and most recently received FDA 510(k) clearance for patients 17 and under in December 2016. The ivWatch Model 400 is backed by 16 years of research and development and includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissues. The sensor is coupled to a highly intuitive pole-mounted patient monitor. The device notifies clinicians if conditions suggest an infiltration, allowing them to address the issue early to reduce patient harm.
“We see this new indication as a milestone for the company. By addressing this gap in health care, we are addressing a need in the pediatric space by offering a solution that will reduce harm to children already faced with medical issues,” states John Lawson, President & CEO, W.M. Jordan Company and ivWatch board member. “To offer this type of proven technology to children will further impact and improve patient safety and outcomes for this at risk population.”
“When we received our first FDA clearance, I stated our goal was to be on every IV pole in the country and provide continuous monitoring of every IV placed,” says Gary Warren, President & CEO of ivWatch. “Our ability to offer our product to both adult and pediatric patients places us one step closer to that goal and solving this significant health care problem.”
To learn more about ivWatch and how to begin an evaluation of the ivWatch Model 400, call 1-855-489-2824, Option 1.
 R.E. Helm, J.D. Klausner, J.K.Klempeer, L.M.Flint, and E. Huang, “Accepted but Unacceptable: Peripheral IV Catheter Failure,” Journal of Infusion Nursing, Vol. 38, No. 3, May/June 2015, pp. 189-203
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June 30, 2016 – Hampton, VA – ivWatch provided its Model 400 devices that continuously monitor IV sites for the early detection of infiltrations to World Pediatric Project for their recent mission to St. Vincent and the Grenadines.
World Pediatric Project (WPP) sends more than forty-five surgical and diagnostic teams each year to provide critical-care health services in a variety of disciplines to children in the Caribbean and Central America. In a single trip, the teams can provide care and treatment for up to 100 children or more depending on the specialty. Between June 19th and June 21st, a WPP neurosurgery specialist team of doctors and nurses evaluated and treated 54 patients and provided 6 children with critical surgical care.
“Partnering with companies like ivWatch allows us to better achieve our mission to deliver access to quality, critical care to children regardless of geography,” stated Susan Rickman, CEO of World Pediatric Project. “ivWatch stepped in and was very supportive in providing their devices as well as a team member to travel with the devices. We are looking forward to working with ivWatch on future missions.”
Dr. Brian Clare, who serves on the Executive Board of World Pediatric Project and is the Chief Medical Officer at ivWatch, facilitated the conversation between the two organizations. “Being involved with both of these organizations, I knew their missions complimented one another,” stated Dr. Clare. “Just as WPP believes geography doesn’t have to be the reason a child lives or dies, ivWatch believes that every patient should have access to technology and devices that will improve patient safety.”
“It was an experience of a lifetime to be a part of this mission,” Marilyn Bowers, ivWatch Clinical Manager commented. “The compassion of the volunteer medical team, World Pediatric Project, the entire St. Vincent medical staff, and the people of St. Vincent was something I will never forget.”
On this most recent mission to St. Vincent, ivWatch provided the WPP team with their Model 400 devices to help monitor the IVs of the pediatric patients that were designated candidates for surgery and through their recovery.
“This device is definitely a game changer and much needed in developing countries,” stated His Excellency Sir Frederick Nathanial Ballantyne, G.C.M.G, M.D., D.Sc., and current Governor- General of St. Vincent and the Grenadines.
Marilyn Bowers was able to capture the mission through photos. More details can be found on the ivWatch website. For detailed information about World Pediatric Project, visit their website at www.worldpediatricproject.org.
Headquartered in Virginia, ivWatch, LLC is a medical device company focused on improving the safety and effectiveness of intravenous (IV) therapy. Our technology aids clinicians by continuously monitoring a patient’s IV, providing early detection of IV infiltrations – when medication or fluid leaks outside the vein into the surrounding tissue. Because peripheral IVs are one of the most common invasive medical procedures performed in the U.S. each year, and current medical reports indicate the failure rate of IVs in excess of 20% due to infiltrations, ivWatch has delivered an FDA-cleared device in order to address this unmet need. For more information, please visit www.ivWatch.com or call at 1-855-489-2824.
World Pediatric Project is a nonprofit, humanitarian organization founded and based in Richmond, Virginia, that provides surgical and diagnostic care to Central American and Caribbean children while creating and implementing programs to heal the children of tomorrow. This mission is accomplished by mobilizing hospitals and teams of generous pediatric specialists, who volunteer their time and expertise to help thousands of children who need critical care, yet have no access to it in their home countries. With the volunteer help of these dedicated doctors and nurses, World Pediatric Project brings children to partner hospitals in the U.S. and sends pediatric diagnostic and surgical teams to developing countries. Thousands of children have received direct services since 2001. For more information, go to www.worldpediatricproject.org or call WPP at 540-282-8830.
1-855-489-2824 ext. 7031
World Pediatric Project
ivWatch recently participated in a surgical mission to St. Vincent and the Grenadines with the World Pediatric Patient (WPP) to help children in need of critical care. ivWatch sent its Model 400 devices that continuously monitor IV sites for the early detection of infiltrations. Marilyn Bowers, ivWatch clinical manager, went to help with the set up of the devices and provide device education to the recovery and bedside RNs. We were extremely excited to provide our support and devices for use during the surgeries and procedures.
During her journey, Marilyn was able to document her experience with the talented team of volunteer doctors and nurses, the medical team in St. Vincent, and the importance of what the World Pediatric Project does every day and across the Caribbean and Central America.
During the St. Vincent mission, a WPP neurosurgery specialist team of doctors and nurses evaluated and treated 54 patients and provided 6 children with critical surgical care. The team members included: Dr. Gary Tye, Neurosurgeon from Children’s Hospital of the King’s Daughters, Dr. Rafael Vega, Neurosurgery Resident at Virginia Commonwealth University Medical Center, Dr. Jay Shapiro, Anesthesiologist and JoAnn Tillett, both from Children’s Hospital of Richmond at Virginia Commonwealth University, and Joanne Pollard from CJW Medical Center (Chippenham Hospital & Johnston-Willis Hospital). The next training mission is scheduled for September 18-22, 2016 and will be a general surgery mission with a heavy focus on training on laparoscopic surgical technique.
Saturday, June 18 – Travel Day
Marilyn made it to St. Lucia without issue but had to deplane the flight to St. Vincent due to mechanical issues. After a few hours’ delay, the flight took off with one stop at Union Island where all the passengers (except her and the pilots) departed, she made it to St. Vincent. She was greeted by Nurse Jackie and headed to Young Island.
Sunday, June 19 – Set up day in OR
The team met for breakfast and made their way to the hospital for clinic and to prepare the OR for the upcoming surgeries. There was an issue with the original boat – so the team made the best of it and hopped on the other boat provided. Though a bit wet from rain and waves – they started in on set up and initial patient interviews.
They were introduced to some of the medical staff at the hospital. All of the families that were to be seen by the doctors were waiting along the halls and outside. Many of the families traveled from surrounding islands just to be seen by the WPP team of volunteers, doctors and nurses. All of the families were so kind and appreciative as they waited patiently for their turn.
Marilyn commented on how the hard the medical team worked to get patients seen and the OR set up for the early start time on Monday.
Monday, June 20 – Surgery Day 1
The first set of surgeries and procedures began at 6:30 AM. Below are images of the team, including the St. Vincent medical team, the ivWatch Model 400 in the OR and the device in use on some of the surgical patients.
Tuesday, June 21 – Surgery Day 2
Tuesday began at 6:30 am again with another day of back to back surgeries and procedures. Dr. Ellis, part of the St. Vincent medical team was ready to assist the WPP team in surgery.
After the first surgery, the patient, baby Peyton, was moved to the recovery room. The team had commenced the second surgery in the OR, when the nurses from the recovery room informed Marilyn that the ivWatch device was indicating a possible infiltration, despite the fact that the nurses could not see the infiltration. The decision was made to restart the device. Approximately 20 minutes later, the recovery nurse called into the OR and indicated the device was indicating an infiltration for the second time. At this point, the recovery nurses were able to see the infiltration, so the location of the IV was changed. The ivWatch device was placed next to the new IV site to continue monitoring during Peyton’s recovery.
The WPP also team included medical students that were able to help and observe the procedures.
Wednesday, June 22 – Follow up day
Wednesday morning, Dr. Tye, Dr. Vega, and Jo Ann, and Marilyn headed over to the hospital to meet with the St. Vincent Medical team to check on the recovering patients and check the ivWatch devices. The most important news of all is that all of the patients looked as if they were on their way to a healthy recovery.
ivWatch continues its investment in growth by having John Gahan join as Vice President of Manufacturing. He officially joined ivWatch during the first quarter of 2016.
Mr. Gahan has over 30 years of experience in engineering and facility management within highly regulated industries including medical device manufacturing, pharmaceutical, optical manufacturing, and nuclear power. He joins ivWatch from Luxottica Optical Manufacturing where he held multiple engineering and facility leadership positions throughout his tenure. Immediately before joining ivWatch, he served as Engineering Director and was responsible for the installation of new manufacturing operations, testing and development of new manufacturing lines, and served as the lead for Environmental, Health & Safety initiatives.
Prior to his roles at Luxottica, Mr. Gahan held positions in various organizations where he led automation efforts in manufacturing and assembly processes in clean-room environments, as well as the redesign of manufacturing lines in order to meet high demand while creating manufacturing flexibility. His experience includes managing the production and manufacturing processes in large facilities, while adhering to strict regulations such as FDA, ISO, state, federal, environmental, and safety.
In his role of Vice President of Manufacturing at ivWatch, Mr. Gahan is responsible for developing and maintaining the manufacturing processes, and ensuring compliance with medical device quality standards. He will play an active role in our business that makes a difference in improving patient care.
Hampton, VA – May 3, 2016 – ivWatch, a medical device manufacturer focused on improving the safety and effectiveness of intravenous therapy (often referred to as an “IV”) through early detection of infiltrations, today announced that the U.S. Patent and Trademark Office has issued to ivWatch a key patent regarding the use of light to detect if fluids are leaking from an IV.
U.S. Patent No. 9,326,686, titled “System and Method for Mitigating the Effects of Tissue Blood Volume Changes to Aid in Diagnosing Infiltration or Extravasation in Animalia Tissue,” includes claims for detecting such leaks while dealing with the physics associated with patient movement.
The technology behind this patent directly relates to the ability of the ivWatch Model 400 to reduce the number of “false” alarms for our product and not contribute to the ongoing issue and syndrome known as “alarm fatigue”. This serious issue garnished the attention of the Joint Commission back in June 2013, when alarm safety was set as a national patient goal. A recent WSJ article stated that as many as 90% of alarms are false or don’t require any immediate attention. But when clinicians become desensitized to the alarms, they can overlook the 10% of the notifications that are critical, and lead to fatal mistakes. A common cause of false alarms from devices is due to patient movement.
The ivWatch Model 400 includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissue seen during an infiltration. Changes in the tissue blood volume associated with patient movement affect the signal primarily by changing the amount of hemoglobin, a dominant absorber, in the underlying tissue. The reading from the sensor is analyzed by the highly intuitive pole-mounted patient monitor. The ivWatch technology is able to analyze and detect infiltrations in common IV therapy settings, allowing the patient to move freely while still being continuously monitored. The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.
“This latest patent demonstrates the depth of the science behind the ivWatch technology. You can’t expect a patient to remain still while they are receiving care. Our breakthrough technology has allowed the ivWatch Model 400 to accurately detect infiltrations without impacting patient mobility,” states Gary P. Warren, CEO of ivWatch. “We expect the hard work and dedication of the inventors of this patent to have a meaningful contribution to the improvement of patient safety. Our product provides a new option for medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors”.
The technology is a core component of the ivWatch Model 400, a FDA cleared device that continuously monitors a patient’s peripheral IV for the early detection of infiltrations, when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs are one of the most common invasive medical procedures performed with over 300 million IV catheters sold in the U.S. annually. Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations which can cause drug delivery errors and patient harm.
The ivWatch announced U.S. commercial availability of the ivWatch Model 400 in April. To learn more, visit www.ivWatch.com.
About ivWatch, LLC
ivWatch, LLC is a medical device manufacturer focused on improving the safety and effectiveness of intravenous (IV) therapy. The company’s technology aids clinicians by continuously monitoring a patient’s peripheral IV, providing early detection of IV infiltrations.
 (Landro, 2016)
The ivWatch Model 400 will improve patient safety through early detection of IV infiltrations and extravasations and provide a new option for IV therapy.
Hampton, Va. — April 5, 2016 — Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400, a device that continuously monitors a patient’s IV for the early detection of infiltrations – when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs (PIVs) are one of the most common invasive medical procedures performed with over 150 million IV catheters placed in the U.S. annually. Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations. The ivWatch Model 400 was developed to address this unmet need in healthcare.
“A procedure that is this common in healthcare should not have such a high failure rate,” said Gary Warren, CEO at ivWatch. “IV failure due to infiltrations is commonly accepted. We need to make it unacceptable.”
Complications of PIV infiltration range from pain and redness to severe tissue damage and amputation. To avoid IV failure, clinicians have defaulted to using other, more intrusive vascular access devices. Peripherally inserted central catheters (PICC), for example, unfortunately carry other serious risks, such as central-line-associated bloodstream infections, commonly referred to as CLABSIs.
The ivWatch Model 400 represents a new option for medical professionals – a continuously monitored IV – that can allow peripheral IVs to be an appropriate alternative for infusion therapy that can reduce costs, risk, patient harm and medication dosing errors. The ivWatch Model is the result of more than 16 years of intensive development and clinical testing. The FDA cleared the device for use in 2015.
“It’s like a seatbelt,” said Warren. “Since it’s difficult to predict when an accident will occur, people wear their seatbelt for the duration of their travel. Similarly, since it’s difficult to predict when an infiltration will occur, and we know it occurs too frequently, the ivWatch Model 400 represents a seat belt for patients with an IV. Our continuous monitoring device not only improves patient safety, but can help minimize the risk and avoidable costs for health care provider organizations.”
The device includes a non-invasive sensor that uses visible and near-infrared light to detect changes in the optical properties of the tissue. The sensor is coupled with a highly intuitive, pole-mounted patient monitor. The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.
About ivWatch, LLC
Headquartered in Hampton, Virginia, ivWatch is a medical device manufacturer focused on improving patient safety and effectiveness of IV therapy. The company’s technology aids clinicians by continuously monitoring a patient’s IV, providing early detection of IV infiltrations and extravasations.
Please contact Melissa Fire, Vice President of Sales, for information on pricing and evaluation opportunities at firstname.lastname@example.org or 757-817-9040.
Director of Marketing, ivWatch, LLC
1.855.489.2824 ext. 7031