Venous access is famously difficult in many patients, and devices have been developed in the past to make veins easier to see. Seeing narrow veins doesn’t make it much easier to get inside of them, but the Veinplicity device from Physeon, a Swiss company that’s part of Germany’s Novintum Medical Technology, actually makes veinsmore engorged and less of a challenge to access.

We spoke with Pat Kullman, CEO of Physeon, and Tina Leggett, Physeon’s Business Development Director, to find out more about the technology within the Veinplicityand what it means for everyday clinical care.

Before we dive in, to get an idea of the product here’s a video showing how the Veinplicity system is used:

Medgadget: Where did the concept for the Veinplicity device come from?

Pat Kullman: The concept originated with Dr. David Phillips, MD, PhD, inventor of the infrared ear thermometer and the Rebuilder medical technology. In 2013, our Founder and Dr. Phillips were exploring opportunities to address chemo-induced peripheral neuropathy when we first saw the potential of this concept and its applicability well beyond the realm of an oncology setting only. Dr. Phillips demonstrated the concept on his wife initially by putting her hands in petri-dishes containing an electrolyte solution and two wiring leads connected to a battery and a motherboard. We’ve come a long way since those early days in 2013.

Medgadget: What was the medical evidence that you were working with?

Kullman: Venous access is the most commonly performed procedure in the world. In the US alone, there are nearly 1B access attempts each year. Statistical evidence suggests first stick failure rates at 20-50%. And while we see a lot of visualization technologies on the market, there’s absolutely nothing that has physiological impact on the veins themselves….until Veinplicity, that is…

Medgadget: How does the Veinplicity operate?

Tina Leggett: By applying a mild electrical current to the forearm, Veinplicity has a threefold effect – muscle contraction creates increased blood flow; parasympathetic nerve block causes vessel dilation and chemical mediators improve vessel tone

Medgadget: How much electricity is delivered and how would you compare the sensation to something we can all relate to?

Leggett: The device delivers no more than 1mA of current and not more than 90v. You can compare it to the type of mild electrical current you get from a TENS (Transcutaneous Electrical Nerve Stimulation) device, which is used to relieve pain.

Medgadget: How did you personally get into this space? What excites you about Veinplicity as a company and a technology?

Leggett: IV access is the most common invasive procedure performed in clinical settings everywhere in the world. With such a high first stick failure rate, it is one of the greatest challenges faced in healthcare today. It’s something we feel passionate about because first stick failure has big implications for patients, providers and for healthcare professionals alike.

Medgadget: What types of patients is your product intended for and who is it contra-indicated for? Who will benefit the most?

Leggett: Veinplicity is designated for anyone over the age of 2. Anyone with a history of– or risk of –Difficult Venous Access can benefit from Veinplicity. The device is contra-indicated only for patients with implanted electrical devices.

Medgadget: We watched a video demonstrating the use of the Veinplicity system. The patient’s hand and arm undergo quite a bit of shaking, which may have to go on for as long as ten minutes. What are people saying that have experienced the Veinplicity system?

Leggett: The shaking is a physiological side effect of our stimulation of the musculature of the arm, but in no way is it painful. The overwhelming majority of patients describe the sensation as a funny tingling feeling. People with a history of difficult venous access feel it’s nothing compared to a failed stick.

Medgadget: What about the nurses that have used it? What have their experiences been like?

Leggett: Nurses, as well as patients, have been amazed with the results. There is no special training required and no need to change the technique they’ve always used to access veins. Nurses like the fact that the engorged veins not only become larger but also better anchored in the surrounding tissue, which means they don’t roll away from the needle tip. They say that Veinplicity is an critical part of the toolkit – visualization devices can help locate a vein but they can still be difficult or impossible to access, while Veinplicity makes the target easier to reach.

Medgadget: You’re cleared in Europe. How is the system doing there?

Leggett: The first launch country has been the UK, where sales are steadily increasing. In fact, every Apheresis Outpatient Center in the UK carries a Veinplicity device for their patients. We’ve just completed a successful trial in the Netherlands and will use the evidence to spearhead a launch in continental Europe.

Medgadget: What about the regulatory status of the Veinplicity in the U.S.? Are you seeking a 510(k) clearance or is a more difficult pathway required?

Kullman: The pathway in the US will be a de novo pathway approval with supporting clinical data for superiority