When it comes to healthcare Canadians can all agree that it's better to fix a problem early than allow it to get progressively and dangerously worse over time. Yet that is the reality for many people living with atrial fibrillation (AF), a chronic progressive disease affecting between 350,000 and 700,000 Canadians, or about 1 percent to 2 percent of the country's population.

A promising long-term solution is a minimally invasive procedure – called cryoballoon ablation – that uses technologies developed and manufactured by Medtronic (Montreal) and Baylis Medical Company Inc. (Montreal). This procedure is primarily used on patients with later stage AF and not responding to treatment. Researchers believe using it earlier, or closer to the time that AF is diagnosed, would allow many more people to live better lives without a life-long medication regimen.

"The current standard of practice is to give them medicine and when the medicine doesn't work, to then switch over to an ablation," explains lead researcher Dr. Jason Andrade, Director, Atrial Fibrillation Clinic, Non-invasive Electrodiagnostics, and Cardiac Electrophysiology, Vancouver General Hospital. "But this is just treating a symptom. If we start with an ablation, we may be able to fix atrial fibrillation early in its course, which potentially means reducing the risk of stroke and other heart problems down the road."

CANet has brought together government officials, health care authority representatives, industry, academic researchers, engineers, social scientists, and physicians in a clinical trial involving 300 patients at 20 sites across Canada. The study will compare the efficacy of drugs versus early surgical intervention, and simplify the surgery to treat more patients in a cost-effective manner.

The procedure uses a radiofrequency transseptal needle, made by Baylis Medical, and a cryoablation balloon catheter, made by Medtronic, to destroy tiny areas in the heart that cause rapid and irregular heartbeats. Researchers believe using this procedure early in a person's condition (i.e. in younger adults) could stop AF from reoccurring later in life – preventing premature deaths and saving the healthcare system hundreds of millions of dollars in direct and indirect costs. Patients who have the surgery go home within 24 hours and feel recovered within a couple of days.

The study is one of several CANet-funded projects aimed at reducing AF-related emergency department visits and hospitalizations by 20 percent, while opening new markets for Canada's life sciences companies.

"The first priority is to study the efficacy of the technology – is it resulting in better patient care?" asks Dr. Allan Skanes, CANet's AF Track Captain and Director of the Electrophysiology Laboratory at the London Health Sciences Centre.

Money is also a factor. AF is one of the higher cost chronic conditions in the Canadian health care system, and medications are cheaper than surgery – at least in the short term. To address this issue, the project will draw on CANet's interdisciplinary network to study whether the procedure makes sense from a cost perspective.

"If the medicines aren't working and people keep going back to emergency rooms, if they are missing work, if they are not coping well, then that is going to have a huge downstream cost," says Andrade. "So to look at that, we have healthcare economists who are trying to figure out at what point is the ideal time to intervene."

As Skanes noted, "The procedure needs to be both cost effective and good for patients," when compared to the current drug protocol.

Opening new markets for Canadian tech

The cryoablation balloon catheter was invented in Quebec by CryoCath Technologies, which has a long history of collaborating with researchers at the Montreal Heart Institute, including Andrade and many others now associated with CANet. Medtronic acquired CryoCath Technologies in 2009, and since then has expanded its R&D and manufacturing workforce to over 550 in Quebec, while continuing to collaborate with academia, including seven current projects with CANet. Medtronic Canada's president, Neil Fraser, also sits on CANet's board of directors and business advisory committee.

Medtronic already produces more than 100,000 cryoballoon units annually, with the majority sold to international markets. The device is able to reduce surgery times by about 20 percent – an important consideration for hospitals that want to offer the procedure to more patients. Previous studies have also shown cryoablation has longer term benefits compared to drug therapy.

Yet, despite these advantages, the company still faces challenges in growing its market.

"As we have experienced, just because a clinical research trial has positive results does not mean it will be adopted by the healthcare system," says Allison Rubino, Clinical Research Manager at Medtronic Canada. "Scientific articles don't always translate into clinical practice because not all stakeholders were involved and aligned from the beginning. What's great about the NCE is it's a more structured framework that creates an acceptable mechanism to bring together all these healthcare stakeholders to create knowledge and then put that knowledge into practice. EARLY–AF is an important trial for Medtronic to understand the value of cryoablation used earlier in the AF disease process. I don't think this study would have happened in Canada had it not been for CANet."

The other industry partner in the trial, Baylis Medical, invented what Skanes describes as a "slicker and more useful version of the age old blunt needle technique" so that physicians can gain access to the left side of the heart. Once the puncture is done, Medtronic's cryoablation balloon catheter can be navigated into the left atrium to treat the arrhythmia. The CANet trial will examine how the Baylis transseptal tools including the NRG FR Transseptal Needle, TorFlex Sheath, and ProTrack Wire compares to standard transseptal tools.

"We have been involved with CANet right since their very beginning and can definitely say we would not be anywhere near where we are today without them," says Kris Shah, president of Baylis Medical. "CANet has helped us accelerate our product development and improve on the design of our medical devices, including SupraCross^TM system (which enables transseptal access from the neck). We have since launched that product in Europe, Canada, and U.S. and it has had a very positive impact on our company."

Shah is hoping for similar success with the EARLY-AF trial. "Just being part of the study has been very helpful to us in that all the Canadian sites will have an opportunity to use our technology and make suggestions on how to improve it," says Shah. "And if, as we hope, the results from the study are positive, it will help us immensely to market the device globally."

Baylis generates about 98 percent of its sales from exports and forecasts growing its Canadian operations from about 250 to 400 employees by 2020. The company's new $40 million R&D and production facility in Mississauga, Ontario will enable it to increase production, expand its product portfolio and branch out to new global markets.

"Both of these companies have market share, and this partnership with CANet is a real opportunity to move into populations they haven't reached before," says Skanes. "It's a win for patients and a win for made-in-Canada technologies."