UroDev Medical (formerly Spinal Singularity), a medtech company based in Minneapolis, has developed the IntelliFlow Bladder Management System, a wireless urinary catheter that can be controlled with the touch of a button on a remote control.
At present, patients with urinary retention may have to use up to 200 disposable urinary catheters a month. This is not only inconvenient, but can cause complications, including infection. It can also be expensive.
To address these issues, UroDev Medical has created the Intelliflow. The catheter can reside in place for a week, meaning much fewer catheter changes. A magnetic valve pump within can be opened to allow for urination, and then shut using a wireless controller outside the body. The pump actively dispels urine from the bladder to allow for more complete emptying.
The company was originally founded by Derek Herrera, a veteran who was shot and paralyzed in Afghanistan, and who was inspired to develop a better solution for urinary retention. You can watch Derek’s story:
Here’s an explanatory video of how the Intelliflow system works:
Medgadget had the opportunity to speak with Matt Monarski, President and CEO of UroDev Medical, about the technology.
Conn Hastings, Medgadget: Please give us an overview of chronic urinary retention, its causes and its effects on patient quality of life.
Matt Monarski, UroDev Medical: Urinary retention is the difficulty or inability to empty the bladder. Patients who require chronic catheterization are unable to urinate on their own and experience severe discomfort in their lower abdomen and urinary tract. The standard of care for patients who require chronic catheterization to empty their bladder is intermittent catheterization, which uses disposable urinary catheters to empty the bladder approximately 5–7, or more, times per day. This results in the use of about 50 or more urinary catheters a week, or more than 200 a month. Every year in the U.S., 30 million urinary catheters are used by over 5 million adults with urinary retention who require catheterization to empty urine from the bladder.
The need to manage the bladder through chronic catheterization imposes a dramatic burden on a patient’s quality of life, with most hospitalized individuals citing the loss of bladder and bowel control as a prospect worse than death. Not only is it inconvenient for patients to self-catheterize themselves daily, but the quality of life for caregivers can be impacted as well if patients are not able to catheterize themselves – especially if those caregivers are partners or family members.
Medgadget: What difficulties do conventional urinary catheters pose for those who need to use them regularly or permanently?
Matt Monarski: Complication rates associated with standard intermittent urinary catheters are enormous. They can impose a high risk for infection due to false passage or urinary tract infections, and the financial burden is significant – it costs between $2 and $8 per catheter, which results in about $400–$1,600 per month for one person.
Medgadget: Please give us an overview of the IntelliFlow Bladder Management System, and how it works.
Matt Monarski: The IntelliFlow Bladder Management System is a semi-permanent, non-invasive, smart catheter system that allows the user to control a valve to empty urine from the bladder, eliminating the need for intermittent or indwelling catheters with external drainage bags attached to the body to collect urine.
IntelliFlow is placed completely inside the body to reduce the risk of infection. It enables users to empty their bladders comfortably and conveniently, and can be inserted or removed by the user or clinician quickly and easily. Compared to about 50 or more standard urinary catheters a week for a single patient, only one IntelliFlow catheter is required per week to manage a patient’s bladder control.
Medgadget: How did the idea for the IntelliFlow Bladder Management System come about?
Matt Monarski: The company was founded in 2015 by Chief Technology Officer Derek Herrera, a former Marine Special Operations Officer who was shot in Afghanistan in 2012. A bullet went into his shoulder and lodged in his spine, resulting in paralysis from the chest down and requiring chronic catheterization from then on. When he was discharged and returned to the U.S., Derek earned his Master of Business Administration and was driven by his personal experience with paralysis and chronic catheterization to think of a better solution for his permanent urinary retention. This led to the development of IntelliFlow, which is designed for anyone living with bladder dysfunction that requires chronic catheterization.
Medgadget: Please give us an overview of how patients have found the device during clinical trials, either past or ongoing.
Matt Monarski: IntelliFlow has been used in more than 40 patients to date and is currently being evaluated in 40 additional patients in a pivotal clinical trial, the FREEDOM Study. Patients consistently rate IntelliFlow higher than intermittent catheters in every category measured, including satisfaction, convenience, ease of use, comfort and speed.
Medgadget: When do you envisage that the technology will be available?
Matt Monarski: UroDev plans to submit IntelliFlow to the FDA for 510(k) clearance in mid-2021 and has already applied for Breakthrough Medical Device Designation, which will speed up the FDA’s review process if granted. If we receive FDA clearance before the end of the year, we plan to initiate a limited launch in the U.S. by the end of 2021. The U.S. rollout will continue in early 2022, and we’ll commercialize in select European countries once we receive CE Mark approval.
Link: UroDev Medical homepage…