Minnesota-made Veinplicity device aims to make IV access easier

No one likes being stuck with a needle to get intravenous fluids in the hospital.

But worse than being stuck once is having it done twice. Or three times. Or as many times as it takes before the clinician can establish a good vascular connection.

A small 2017 study examined hundreds of Italian patients and found it took between 45 seconds and 125 minutes to insert an IV needle. Yes, that's right — 125 minutes of needle sticks and extra work to coax an IV needle into a good vein for an IV line.

A Swiss company called Physeon GmbH is testing a medical device designed and manufactured in Minnesota to make difficult IV access easier and less stressful. The device, called the Veinplicity, applies electric stimulation to the patient's arm for a few minutes to make veins easier to target with an IV needle. The current makes the veins temporarily grow larger and more prominent in the arm, making it easier to place the IV needle on the first attempt.

A clinical trial called Viva is being conducted with the device at Mayo Clinic in Rochester, Regions Hospital in St. Paul, and the Midwest Immunology Clinic and Infusion Center in Plymouth. The trial is testing whether the device speeds up the time to successful IV placement, and also whether that reduces patients' pain and anxiety.

"This is a very exciting technology, in a not so highly visible part of medicine, but probably the most important part of medicine that I've been involved with in my career," said Physeon CEO Patrick Kullmann, a serial med-tech entrepreneur whose past work includes time as an executive at Microvena and Medovex Corp.

Although Physeon is based in Switzerland, Kullmann works from offices in Bloomington, and the device itself is designed and made by Minnesota electronics manufacturing outsourcer Nortech.

The potential market for the Veinplicity is estimated to be large. In the United States, more than 36 million people were admitted to acute-care hospitals in 2017, and inserting an IV cannula (or needle) was among the most common procedures performed on them. Once an IV cannula is in place in the vein, it can be attached to the line connected to a bag of fluids or medication on the IV pole next to the hospital bed.

But past studies have found that between 10 percent and 40 percent of cannulae fail to go in correctly on the first try. The clinician's level of experience is a major factor in the difficulty of vein access, but patient conditions can also make it more difficult, especially obesity, unusual vein placement, past IV chemotherapy and intravenous drug abuse.

"A delay in establishing vascular access can result in a delay in the administration of fluids and/or medications," the Emergency Nurses Association wrote in its 2012 practice guidelines for difficult venous access. Patients with difficult IV placement "frequently experience delays in diagnosis and initiation of treatment. In addition, multiple attempts at attaining vascular access result in frustration and a loss of productivity."

It also hurts more. Getting multiple needle sticks instead of just one can induce anxiety in patients. And as Physeon notes in its promotional materials, anxiety is a "major contributor" to patient dissatisfaction.

The Veinplicity is not the first medical device intended to make IV placements easier.

The ENA guidelines said ultrasound guidance can help clinicians see exactly where to place an IV cannula, resulting in a high success rates in past studies with clinicians trained on the technique. An older but well-proven technique is "intraosseous" vascular access, which involves placement of a needle in bone to inject fluids directly into the marrow. Other methods include using near-infrared light to illuminate veins under the skin.

In the U.K., a small clinical trial compared the use of the Veinplicity device with heat packs, another common tool used to make veins more prominent. The study found that the Veinplicity patients had a 49 percent increase in vein diameter, compared to a 36 percent increase with heat treatments, and the "dilatory" effect from the electric stimulation lasted longer than with heat treatment.

The study report, published in January in the Journal of Vascular Access, said there were no clinical complications related to the device. The majority of the Veinplicity patients in the U.K. study felt "involuntary muscle twitching and a tingling sensation," but it was not painful.

"The device is only on for about five minutes, on average. It's not a long stimulation," said Mary Kay Kessinger Sobcinski, a registered nurse and senior consultant on clinical trial design with St. Louis Park's RCRI Inc., which is running the clinical trial sites in the ongoing Viva trial.

The device is legal in some European nations, but not in the U.S. The ongoing U.S.-based trial at the three sites in Minnesota aims to recruit more than 200 people who will be randomized to either the Veinplicity or a traditional IV-start technique. Prices are not set for the prescription-only device.

Joe Carlson • 612-673-4779