Precise Guidance

Made-in-Ontario imaging devices seek to redefine the landscape of interventional cardiology

If a picture is worth a thousand words, then what is the value of one that helps doctors navigate the heart’s delicate terrain to repair lethal conditions?

That’s the million-dollar question Dr. Brian Courtney, a clinician-scientist in the Schulich Heart Research Program at Sunnybrook Research Institute (SRI), is investing his time and energy into answering. Courtney is compelled to provide better image guidance so that doctors like him can manoeuvre through the heart and its channels with greater safety and precision.

“I love looking after patients and trying to provide them with some solution to the challenges they face. If I were to do clinical work 100% of the time, knowing how many technical challenges we face and how many conditions we’d like to be able to treat better, I’d be a bit frustrated. I studied engineering as my initial profession—I like to go after problems and solve them with technical and other solutions,” he says.

Courtney has spent much of his career developing devices to improve outcomes of minimally invasive procedures. In 2007, he founded Colibri Technologies to put these tools in the hands of those who mend ailing hearts and vessels.

Colibri’s first product is an ultrasound catheter that makes 3-D pictures inside the heart in real time. It’s used for intracardiac echocardiography, a technique whereby a catheter with an ultrasound probe at the tip is inserted into a leg vein and guided up into the heart. Intracardiac echo is gaining traction in procedures for structural heart disease and arrhythmia, when the heart beats irregularly.

First, a primer on the heart. This fist-shaped pump is divided into four chambers. The left and right atria, which receive and collect blood, form the upper chambers. The lower chambers, the left and right ventricles, pump blood out of the heart to the rest of the body. An internal wall called the septum divides the right and left sides.

Atrial fibrillation (AF) is when the heart beats abnormally—too fast, too slow or somehow out of sync. It affects about 250,000 Canadians, which makes it the most common heart rhythm problem. It’s caused by an electrical disturbance in the atria.

Staying the Course

Moving a medical innovation from an idea through to a saleable product takes dedication and time—lots of it. Here, a look at some milestones in Colibri’s commercialization pathway of the intracardiac echocardiography (ICE) system.

20062006: Idea for the ICE catheter is born.

20062007: Courtney files for patent protection of the device.

20082008: First images from the ICE catheter are made.

20082010: First major private investment in the company. Colibri hires its first employee.

20082011: Initial preclinical data are acquired. 

20122012: Colibri moves into its head office and R&D facility. The company receives certification for manufacturing. 

20142014: Japan Lifeline, a medical equipment company, becomes sole distributor of ICE technology system in Japan.

A prolonged too-fast heartbeat can lead to heart failure when the weakened muscle can’t pump enough blood throughout the body. Atrial fibrillation also increases the risk of stroke five-fold. This is because the atria contract in a chaotic pattern; thus, the heart doesn’t pump effectively, causing blood to pool, which could lead to the fatal ascent of a clot to the brain.

Anticlotting drugs and medication to control heart rate and rhythm are a first-line strategy for reducing the risk of stroke and symptoms caused by AF. If patients can’t tolerate them, then they might undergo cardiac ablation, a procedure that’s done in Canada several thousand times annually. The aim is to alter the heart muscle that initiates and propagates faulty signals that cause the arrhythmia.

Some electrophysiologists, who are cardiologists specialized in treating such problems, rely on X-ray guidance during ablation procedures, especially if the patient’s anatomy is normal. That often isn’t the case, though, says Courtney. “That’s one of the reasons why people might have atrial fibrillation, because they have something different about their heart.”

For common heart procedures, including AF ablation, doctors move from the right side to the left by making a small hole in the atrial septum. The left atrium is the trickiest chamber to enter, and where ultrasound guidance is advantageous, says Courtney.

Dr. Bradley Strauss a senior scientist at SRI and chief of the Schulich Heart Program at Sunnybrook, where he works as an interventional cardiologist, agrees. “Sometimes you go through [the septum] where you don’t want to go through, and puncture the heart or do something that’s very dangerous, especially for people who don’t have as much experience doing it. The idea that you can actually see where you’re going is very helpful.”

Other companies make catheters, but Courtney’s intracardiac catheter is the only one that is forward-viewing and can do 2-D and 3-D imaging.

Strauss, who has evaluated the device and made a minority investment in Colibri, says being able to see ahead of the catheter is a game-changer. “Imagine doing some of the dangerous things we do and not knowing precisely where you’re going. That we can do it without that guidance is amazing, [but] every once in a while, even with experience, you get misled or make a mistake. This will ensure it’s safer and more accurate.”

The device could also transform how catheter-based mitral valve procedures are done. Here, doctors stop leakage of blood from the left ventricle to the left atrium by attaching a clip to the mitral valve to keep it closed. It’s guided by a technique called transesophageal echo, which uses ultrasound to see inside the heart but goes in through the esophagus and requires general anesthesia. Using intracardiac echo instead requires only local anesthesia, a faster, cheaper option.

In addition to providing more anatomical context, the 3-D component of the imaging could help doctors do their work more handily.

“When you’re doing these procedures, you have one device that’s either burning, sensing or clipping, and you have another catheter that takes pictures. If you have a 3-D catheter, that gives you more flexibility in being able to position your imaging catheter in other locations that are less likely to interfere with the movement of the catheter that’s doing the therapy,” says Courtney.

Welcoming the Hybrid Age

Colibri’s second product, its intravascular catheter, is an innovation that could help cardiologists to determine better the nature and extent of coronary artery disease, narrowing of the coronary arteries that is the leading cause of death worldwide. The device combines two complementary ways of seeing inside blood vessels: ultrasound and optical coherence tomography (OCT).

Intravascular ultrasound can identify attributes such as plaque build-up or calcifications on the artery wall that are difficult to make out on an angiogram, a picture of the coronary arteries made using X-rays and a dye. It’s also used to see whether a stent has been placed correctly or to determine the right-sized stent.

Optical coherence tomography, which makes pictures by sending light into tissue and collecting the reflections, is a newer technique that provides higher resolution and better contrast than does ultrasound. Where ultrasound prevails is being able to see deeper into tissue and looking through blood.

Colibri’s intravascular catheter aligns the ultrasound and OCT beams exactly so that they look in the same direction concurrently. The design enables data from both modalities to be matched precisely for a more detailed image inside the vessels.

The device offers hope in detecting “vulnerable” plaque, which is prone to rupturing. If this happens, then a life-threatening clot forms inside the artery, which can lead to a heart attack or stroke. Catching the buildup before it bursts—which can be symptom-less, as was the case for the plaque that caused the death of NBC journalist Tim Russert in 2008—isn’t possible with current diagnostic methods.

Courtney has presented research on the technology at conferences, which has generated buzz from his colleagues. “It’s clear that there’s a need. We have a path to get there. It’s just a matter of putting the fuel in the tank to get to that point.”

Nearing the Finish Line

Development of the intracardiac catheter is the company’s primary focus, says Courtney, who began working on the technology seven years ago. In the early stages, he and his team built a prototype and did validation testing and preclinical experiments at SRI.

Since then, Colibri has moved into its own space. Its 25 employees are working to propel the technology from a prototype to a market-ready product. The team has concentrated on image quality and reliability, and making the device sterile and biocompatible. In addition to ensuring safety, the team has miniaturized the catheter and modified the design so it can be manufactured. Colibri will seek regulatory approval for clinical use, with an eye to doing do patient studies later in 2015.

While the first two products target applications in cardiology, there are plans to expand into other clinical domains. Colibri has acquired the rights to an ultrasound probe for imaging in the ear that was developed at Dalhousie University in Halifax, N.S. The device will become part of a pipeline of products. “The philosophy is to make a company that has a broad technology platform so we can be the best at providing imaging guidance for minimally invasive procedures,” says Courtney.

Colibri’s first product is the catheter with an ultrasound probe at the tip that can take 3-D pictures inside the heart in real time.

The global market is paying attention: Japan Lifeline, a firm specializing in cardiovascular medical equipment, recently agreed to become the exclusive distributor for Colibri’s intracardiac catheter in Japan. The deal gives Colibri a foothold in the world’s second-largest medical device market.

The company’s dogged pursuit of success is remarkable against the somewhat gloomy backdrop of commercialization of innovations in Canada.

A study by the C.D. Howe Institute shows that per capita patent filings in Canada are declining. Moreover, the country’s medical device sector operates at a $5 billion trade deficit; we buy $7 billion worth of medical equipment from the rest of the world while selling just $1.8 billion of our own.

The path to bringing his inventions to market has been bumpy, and the stakes are high, but Courtney says the cost of sitting on the sidelines is even greater. “If people get too fearful of participating in the innovation process, then Canada will not be the one to innovate and we’ll be buying expensive technologies from elsewhere in the world, or not, and therefore not treating our patients as effectively.”

He’s all in.

Courtney’s research was supported by the Canada Foundation for Innovation, Canadian Institutes of Health Research, Federal Economic Development Agency for Southern Ontario, Health Technology Exchange, Natural Sciences and Engineering Research Council of Canada, Ontario Centres of Excellence, and Ontario Ministry of Research and Innovation.