Medical and technology leaders advise ivWatch, LLC on devices to improve patient safety

Williamsburg, Va.—December 23, 2015—Nationally recognized experts in fields ranging from anesthesiology to infusion nursing are helping ivWatch, LLC develop next-generation devices to improve patient safety. The five leaders are members of a Clinical Advisory Council for ivWatch, which soon will launch its continuous monitoring device to minimize injuries from intravenous (IV) therapy.

IV infusion is the most common invasive hospital procedure performed worldwide, but IVs can fail as often as half the time. When they fail, fluid or medication enters the surrounding tissue rather than the patient’s vein — a condition called peripheral IV infiltration — resulting in complications that range from pain and redness to severe tissue damage. Because of this failure, clinicians have defaulted to using other more intrusive vascular access devices that have other serious risks, such as central-line-associated blood stream infections, commonly referred to as CLABSIs.

The ivWatch Model 400 enables an IV to be continuously monitored, aiding clinicians in the early detection of infiltrations by automatically notifying them. The FDA has cleared the device for use with adults and it will be available for sale early in 2016.

“Our Clinical Advisory Council includes highly experienced vascular experts and other clinicians who’ve dedicated themselves to the mission of protecting patients,” said Gary Warren, CEO at ivWatch. “Their input has been invaluable in developing our inaugural safety device, and they are active contributors to other technological advances in our pipeline.”

The ivWatch Model 400 includes a patient monitor, a non-invasive sensor using visible and near-infrared light, and a disposable sensor receptacle applied next to the IV site. A color LCD screen displays the status of the IV and an audible notification sounds if an infiltration occurs.

The Clinical Advisory Council members include:

Gregory J. Schears, MD, Advisory Council Chairman and Chief Clinical Officer

Dr. Schears serves in a variety of roles at Mayo Clinic in Minnesota. He is medical director for ECMO Services, a physician liaison for the Nurse PICC Team, co-medical director of the Cardiovascular Pediatric Surgical ICU and a consultant for the Department of Anesthesiology. Dr. Schears also is a practicing pediatric intensivist and anesthesiologist, and serves as an associate professor of anesthesiology at Mayo Clinic College of Medicine.

Lisa Gorski, RN, MS, CS, CRNI

Ms. Gorski — a clinical nurse specialist with Wheaton Franciscan Home Health and Hospice in Wisconsin — is nationally recognized for her expertise in infusion nursing and chronic illness. Ms. Gorski is widely published on the topic of home-infusion therapy, including the 2010 textbook, “Infusion Nursing in Clinical Practice: An Evidence-Based Approach.” She also is past president of the Infusion Nurses Society.

Melissa C. Whitehead, BSN, RN, CPN, CRNI

Ms. Whitehead is clinical manager for seven teams at Children’s Medical Center in Dallas, Texas. Those teams include Vascular Access, the Wound-Ostomy-Continence Program and Patient Care Technicians. Ms. Whitehead is a member of the Association for Vascular Access and the Infusion Nurses Society. She has presented on numerous topics, including common complications of PIV therapy and current methods used to help minimize complications.

Liz Sharpe, RN, DNP

Ms. Sharpe is a neonatal nurse practitioner and educator, with a special interest in vascular access in neonatal and pediatric patients. An assistant professor at the University of Alabama’s School of Nursing, Ms. Sharpe also serves on the board of the National Association of Neonatal Nurses and the Vascular Access Certification Corporation. She is active in the Association for Vascular Access and the Infusion Nurses Society, and is an author, reviewer and consultant on the topic of vascular access.

Steven Bierman, MD, Chief Medical Officer at Access Scientific

Dr. Bierman founded Venetec International in 1996, which set a worldwide safety standard for management of intravascular and urinary catheters. The company sold to CR BARD in 2006. His new company, Access Scientific, LLC, is dedicated to establishing a new standard of over-wire vascular access.

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About ivWatch, LLC

Headquartered in Virginia, ivWatch develops, markets and sells biomedical sensor technology focused on improving patient safety in infusion therapy and vascular access. The company’s inaugural device, the ivWatch Model 400, is a first-of-its-kind continuous monitoring device, cleared by the FDA, which quickly alerts providers of possible peripheral IV infiltration.

The concept for the ivWatch Model 400 originated in 1999, and is the result of more than 14 years of intensive development and clinical testing. These efforts have led not only to the development of the ivWatch Model 400, but the technology has also resulted in 60+ utility patents that will be used to continue to improve patient safety in other ways.

More information is available at ivwatch.com.

 

Biotech innovator ivWatch LLC expands to Hampton

Oct. 13, 2015 – ivWatch LLC, a biomedical sensor technology company focused on improving patient safety in infusion therapy and vascular access, will soon expand to a 7,000-square-foot location in Hampton.

The new location, within The National Institute of Aeronautics building on Exploration Way, will allow ivWatch to house its manufacturing department under the same roof as the rest of its operations. The company currently has 14 employees and expects to double that number by early 2016. Leah Moore, director of marketing for ivWatch, said they will begin moving into the new location this December.

The company is streamlining its operations and expanding its staff in preparation for the launch of its inaugural medical device. The ivWatch Model 400 is a first-of-its-kind continuous monitoring device used to assist medical professionals in detecting when intravenous fluids have leaked out of a patient’s vein and into surrounding tissue, commonly known as an infiltration. The device has received FDA clearance for use with adults 18 and over.

“By unifying our operations in the NIA building, we’ll have the space we need to grow and the opportunity to contribute to the local economy,” said ivWatch CEO Gary Warren, who worked for NASA early in his career.

“This new location allows us to build our product components on-site, as we continue hiring professionals in the health and engineering industries to expand our portfolio of products and technology that improve patient safety,” Warren said.

Hampton Mayor George Wallace said: “I am pleased to welcome ivWatch as the newest member of Hampton’s business community. The company’s decision to choose Hampton supports the city’s efforts to further diversify our local economy. We look forward to being an active part of ivWatch’s growth as the company provides innovative medical devices from their new headquarters and production facility in Hampton.”

ivWatch recently received the $225,000 grand prize in the bioscience sector of the Virginia Velocity Business Plan Competition. The competition is part of Gov. Terry McAuliffe’s strategy for diversifying the state’s economy by encouraging the growth of innovative bioscience and energy companies.

The NIA is a non-profit research and graduate education institute created in 2002 to conduct leading edge aerospace and atmospheric research, develop new technologies for the nation and help inspire the next generation of engineers and scientists.

For more information about economic opportunities in Hampton, go to the Economic Development Department website at www.hampton.gov/ED.

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ivWatch Partners with Cincinnati Children’s Hospital Medical Center for Pediatric Clinical Trial

Williamsburg, Va. — ivWatch, LLC recently began assessing the efficacy of its inaugural medical device, the ivWatch Model 400, on pediatric patients at Cincinnati Children’s Hospital Medical Center. The medical device company works to improve patient safety in infusion therapy and vascular access.

The ivWatch Model 400 is used to assist medical professionals in detecting when intravenous (IV) fluids have leaked out of the vein and into the surrounding tissue, called a PIV infiltration. The device already has received FDA clearance for use on adults 18 and over.

The goal of the pediatric clinical trial is to measure the performance of the device for detecting infiltrated PIV sites of pediatric patients. The phase II pilot study began on Aug. 25, 2015 and is anticipated to last six to nine months.

PIV therapy is one of the most common invasive procedures performed in U.S. hospitals. Failures can occur when the infusate leaks into surrounding tissue. Pediatric patients may be at higher risk of infiltration due to their heightened activity levels, limited communication skills and small limb size.

“As one of the nation’s top pediatric hospitals, Cincinnati Children’s is committed to advancing patient safety,” said Darcy Doellman MSN, RN, CRNI, VA-BC, principal investigator, clinical manager of the Vascular Access Team, and an industry recognized vascular access expert. “The insights we gain by hosting the ivWatch pediatric trial should contribute to improved understanding of IV therapy monitoring practices for pediatric patients across the U.S.”

Co-investigators of the study include Sylvia Rineair, MSHA, BSN, RN, VA-BC, Candice Fletcher Overly, MSN, RN, NSQIP, SCR and Dr. Neil Johnson, an interventional radiologist.

Current nursing practice for monitoring pediatric patients with a PIV involves regular visual and tactile assessment of the PIV site. The ivWatch Model 400 provides continuous monitoring of the IV site and was developed on the premise that early detection of an infiltration may help to minimize patient harm.

The device includes a patient monitor, a non-invasive sensor using visible and near-infrared light and a disposable sensor receptacle applied next to the IV site. A color LCD screen displays the status of the IV and an audible notification sounds if an infiltration occurs.

Ten patients were enrolled in a pilot group, giving clinicians an opportunity to perform the protocol and operate the ivWatch device while researchers could make any necessary adjustments prior to starting the next phase of testing.

The second phase of the study is now underway and will enroll 150 patients. This phase will allow researchers to compare the difference between the ivWatch Model 400 and standard nursing practices to detect infiltrations. The final phase of the study will enroll another 150 patients and will allow researchers to estimate the notification rate, infiltration size and severity at early stages of an infiltration.

Hospital nursing staff will assess patients’ PIV sites regularly according to the hospital’s existing protocols. The study protocol does not affect the normal care for the pediatric patient.

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Leah Moore, Director of Marketing, ivWatch, LLC
1.855.489.2824 ext. 7031
Leah.Moore@ivwatch.com

 

ivWatch Welcomes Melissa Mullin Fire, Vice President of Sales and Business Development

Williamsburg, Va. – We are pleased to welcome Melissa Mullin Fire to ivWatch as Vice President of Sales and Business Development. She officially joined our team on September 9.

Previous to ivWatch, Melissa served as Vice President of Sales for the Syncera division of Smith & Nephew, a multinational medical equipment manufacturer.

Melissa is an accomplished and strategic healthcare sales leader. She brings over 20 years experience in developing and leading sales teams, launching new products, market development, and channel management for global and domestic markets.

Under her leadership, Melissa’s inspired sales teams brought a myriad of innovative medical products to market, including infusion pumps, IV catheter systems, anesthesia and orthopedic products, monitoring devices and critical care systems.

In her new role at ivWatch, Melissa will be responsible for leading the company’s commercial operations and business development. As we build awareness of ivWatch devices, she will drive market growth and revenue by cultivating relationships with healthcare providers and suppliers, expanding distribution channels and building our sales force.

Melissa holds a BA from the University of Massachusetts in Amherst.

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Leah Moore, Director of Marketing, ivWatch, LLC
1.855.489.2824 ext. 7031
Leah.Moore@ivwatch.com

 

ivWatch Wins First Place in Nationwide Innovation Challenge: Virginia Velocity Business Plan Competition

Williamsburg, Va – September 8, 2015 – This week the innovative work of ivWatch scientists, engineers and clinicians won top honors in a national competition. During a live competitive event held in Richmond, Virginia, ivWatch was awarded first place in the bioscience sector of the Virginia Velocity business plan competition.
The competition is part of Governor McAuliffe’s strategy for diversifying the state’s economy by encouraging the growth of innovative bioscience and energy companies. ivWatch competed against many worthy bioscience businesses from across the nation, all hoping to prove their value to a panel of judges with strong business and industry expertise.

Following two rounds of competition, ivWatch was identified by the panel as one of two finalists in the bioscience sector to compete for the top award.

“We are honored to be singled out for our commitment to innovation that advances patient safety – and proud to be a part of the new Virginia economy,” said Gary Warren, ivWatch CEO.

In addition to being recognized as the best emerging bioscience company in Virginia, ivWatch will receive a $225,000 cash prize to support the company’s growth plans.

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Leah Moore, Director of Marketing, ivWatch, LLC
1.855.489.2824 ext. 7031
Leah.Moore@ivwatch.com

ivWatch Receives FDA Clearance and Significantly Advances Safety of IV Therapy

Williamsburg, Va. – April 9, 2015 – Peripheral IV therapy is a common part of many hospital visits, but it can often result in adverse events that, until now, have been accepted as the norm. The FDA recently cleared ivWatch Model 400 from ivWatch, LLC, a first-of-its-kind continuous monitoring device that will improve patient care by quickly detecting common adverse events: IV infiltration and extravasation. With over 150 million peripheral IVs placed every year in the United States and nothing previously available to continuously monitor them, ivWatch will provide a significant advancement in patient safety.

In the United States, over 80 percent of hospital patients receive peripheral IVs (PIVs) and about 30 percent of these fail. Many of these failures are due to infiltrations and extravasations that occur when IV fluids, called infusates, inadvertently enter the surrounding tissue. Infiltrations are leaks of less-harmful infusates that can cause pain, redness of the skin, and swelling. Extravasations are leaks of potentially harmful infusates such as chemotherapy medications. Infiltrations and extravasations are considered to be medical-dosing errors and, in severe cases, may result in tissue necrosis, loss of function, amputation or even death. The ivWatch sensor technology aids clinicians in the early detection of both types of events.

“I hope this technology will be broadly adopted so that we no longer allow these complications to be the status quo,” said Gregory J. Schears, M.D., associate professor of anesthesiology and physician liaison for the nurse PICC team at the Mayo Clinic. “I believe this will be a paradigm shifting technology, causing a dramatic reduction in the frequency and severity of infiltration injuries that we see.”

Currently, the most widely used methods for detecting these problems are visual and tactile examinations of IV sites by nurses, typically every one to four hours. However, these methods are highly subjective and unreliable. In development since 2000, the ivWatch technology provides continuous assessment to give patients and their caregivers a better solution.

“It’s very rare that one gets an opportunity to be involved in something that can have such a large impact affecting so many people,” said Gary Warren, President and CEO of ivWatch, LLC. “IVs are probably the most common medical procedure performed and 30 percent of them fail, often as a result of infiltration. It’s a huge problem. Others have tried to solve it, but we are the first to develop the technology and bring a practical and cost-effective solution to market.”

The technology developed by ivWatch, LLC uses an optical sensor coupled with a patient monitor. The sensor illuminates tissue near the IV site with visible and near infrared light; the light returning from the tissue is processed by the patient monitor using a proprietary algorithm. Caregivers are notified if conditions suggest that an infiltration or extravasation has occurred.

“This is really a game-changing technology for infusion therapy and should become the new standard of care,” said Darcy Doellman, MSN, RN, CRNI, VA-BC, clinical manager of the Vascular Access Team at Cincinnati Children’s Hospital Medical Center, where clinical trials of the technology have taken place. “This device impacts every unit and almost every patient. For clinicians and patients, this will change the experience.”

This new device will not only improve patient care and safety, but the potential benefits for healthcare providers include:

  • Reduction in medication dosing errors and adverse patient events.
  • Minimized malpractice liability and associated financial and reputation costs.
  • Reduction in the use of PICC lines, which are more invasive and expensive.
  • Improved nurse productivity and reduced medication waste.

The device has gone through extensive testing and rounds of quality improvement, with attention to hardware and software as well as to human factors that account for the patient dynamics and clinician workflow. The patent portfolio for the technology includes over 75 utility patent applications filed in the United States and around the world, with over 60 of those applications published and one patent awarded thus far.

“Our goal is to be on every IV pole in the country and provide continuous monitoring of every IV placed,” said Warren. “This issue is so prevalent and we finally have a way to address it.”

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Leah Moore, Director of Marketing, ivWatch, LLC
1.855.489.2824 ext. 7031
Leah.Moore@ivwatch.com

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