Velano Vascular’s FDA-cleared PIVO device
Hospital patients are often the recipients of an unpleasant early-morning ritual: a wake-up call at 4:30 by a nurse who needs to draw blood to ensure it goes to processing before doctors do their morning rounds.
“Patients being woken up is happening often, and it’s happening for a good clinical reason,” said Chris Waugh, chief innovation officer of the nonprofit Sutter Health network in California. “It can be really frustrating. But what if we can avoid that?”
Slowly, the Sutter Health network is taking steps in that direction by using the PIVO, an FDA-cleared device that uses a patient’s existing, peripheral IV line to draw blood. In the surgical unit at Alta Bates Summit Medical Center in Berkeley —one of 24 different hospital sites under Sutter Health’s purview—more than 100 blood draws have been conducted using the PIVO since mid-November.
“This allows patients to continue sleeping, which is good for recovery. And it makes for a better job experience for the nurse because they don’t have to wake up the patient,” Waugh said, adding that one nurse at Alta Bates has called the PIVO a “miracle” device.
The device itself was developed by Velano Vascular, a San Francisco-based health startup with Philadelphia roots. The idea for Velano Vascular’s PIVO device happened after a seemingly benign question from an elderly patient was posed to Dr. Pitou Devgon, a board-certified internal medicine physician and cofounder of Velano Vascular, according to CEO and cofounder Eric Stone.
“She asked, ‘Why don’t you just draw blood out of this thing,’” Stone recalled, making clear that the “thing” the patient was referring to was her IV line. Devgon ended up building the first PIVO prototype in his kitchen. Four years later, the startup has raised more than $5 million in venture capital, and its PIVO device is in pilot trials in about a half-dozen hospitals across the U.S., including the Children’s Hospital of Philadelphia and the Children’s National Medical Center in Washington, D.C., in addition to Sutter Health’s Alta Bates hospital.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
But an IV line is not an ideal line for drawing blood. The materials used to make IV lines warm up with body temperature, meaning they become “soft like a noodle,” said Stone. That makes an IV ideal for infusing solutions. Pull back on them during a blood draw, however, and they’ll collapse.
The PIVO device, on the other hand, is a soft, plastic tube run through a patient’s IV catheter. Think of a two-way valve that can be section off. In this way, a nurse is able to draw blood without disrupting the patient or the flow of IV solution—or needing to prick a patient’s arm with a needle.
“There’s extension tubing on the IV hub. We attach to that, and advance our device with a syringe on the back. You draw blood, then retract our device,” Stone said.
The device itself is good for one-time use. When more blood needs to be drawn, a nurse uses a fresh PIVO device.
It seems like a simple fix, so simple that Stone said if he “had a nickel for every time I’ve been asked why this hasn’t been done already, I could have funded the company without venture capital.”
But the reason the PIVO is something that works now is because IV technology has evolved. Today, IV lines are optimized for dwell time, so they can stay in the body.
The cost of the device depends on the use case for each hospital.
“We’re just at the point now where we’re evaluating what the price point is going to be for this technology. I’m not at liberty to disclose what it’s looking like. But they’re not going to cost 20 bucks—and they’re not going to cost 20 cents,” he said.
Other companies are also looking at decreasing the friction in how blood is drawn from the body. One Boston-based startup, Seventh Sense Biosystems, has created a device that’s placed on a patient’s arm and draws blood using micro-needles. Seventh Sense Biosystems’ device draws blood from capillaries, whereas Velano Vascular’s PIVO is drawing blood from the vein.
In 2017, Velano Vascular plans to scale its technology and take it to more hospitals. Stone says the startup has seen the technology used in enough patients at enough hospitals to know it works. Now it’s all a matter of “establishing a new standard of care,” he says—and, perhaps, removing the needle entirely from many hospital blood draws.
“Anything that is painless or less painful when you’re sick and you’re trying to get better is great,” he said.
