Providing Much-Needed Relief to Patients with Refractory Angina

Coronary Sinus Reduction

Millions of patients with coronary artery disease (CAD) suffer from refractory angina despite receiving optimal medical therapy and are not candidates for revascularization. However, a game-changer is at hand: Reducer is an innovative technology designed to treat symptoms of refractory angina by creating a permanent, controlled narrowing of the coronary sinus.*

Reducer is a small, balloon-expandable, hourglass-shaped device that establishes a narrowing in the coronary sinus. The resulting increase in back pressure redistributes blood into the ischemic myocardium to help reduce angina symptoms.1 Before Reducer, there were limited options for treating refractory angina. Now, an effective, innovative solution is on hand for patients and physicians alike to improve perfusion to ischemic myocardium.

1: Verheye S., et al. N Engl J Med 2015;372:519-27.

*Reducer is CE-marked in Europe and has been implanted in over 3,500 patients. It is currently under clinical investigation in the US.

CAUTION: In the United States, Reducer is an investigational device, limited by United States law to investigational use. The Reducer is subject of Investigational testing and is being studied in the COSIRA-II trial in Canada. The Reducer is commercially available in certain countries outside the U.S. and Canada. Please contact your local representative for specific country availability. Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events: ifu.neovasc.com

Creating Better Outcomes: Percutaneous Treatment Option for Refractory Angina

Usually a symptom of myocardial ischemia (a lack of blood flow to the heart muscle), angina may feel like pressure or squeezing in the chest and/or pain in the shoulders, arms, neck, jaw or back. Of all patients experiencing angina, many suffer symptoms that are severe, long-lasting and uncontrollable by traditional medical therapies. This severely debilitating condition is known as refractory angina.

Angina pain is often a symptom of CAD, when plaque buildup occurs in the arteries supplying oxygen-rich blood to the heart, forcing the heart to work harder. Many of these patients can get relief from their angina through revascularization from a coronary intervention or surgery. However, 25-40% continue to suffer from angina even after successful revascularization.1,2

Additionally, angina with no obstructive coronary arteries (ANOCA) is increasingly recognized and may affect nearly one-third of patients undergoing invasive coronary angiography for suspected CAD.3,4 These patients do not have plaque buildup as a cause for their angina, and currently have limited options.

1
Abdallah, M. J Am Coll Cardiol 2017;69:2039-50.
2
Stone, G. 2-year results from the ABSORB IV randomized trial. TCT 2019.
3
Patel, M. N Engl J Med 2010; 362:886-895.
4
Samuels, B. J Am Coll Cardiol 2023; 82:1245-1263.

How Reducer Works

Ingeniously Designed for Angina Treatment

coronary sinus reduction device coronary sinus reduction device

Mounting Clinical Evidence

COSIRA-II Multi-Center Study

COSIRA* II is the next-phase clinical trial designed to gather further evidence of the safety and effectiveness of the Reducer system. The study is a US-based, multicenter, randomized, double-blind, sham-controlled trial. ClinicalTrials.gov Identifier: NCT05102019

COSIRA II Multi Center Study video thumbnail

Reducer-I Prospective, Multi-Center,
Post-Market Study

In September 2021, interim results from the REDUCER-I trial augmented the findings from the initial COSIRA trial.1 Patients were enrolled at 20 centers and followed up to 2 years.

  • 82% of patients improved 1 or more CCS angina classes at 2 years.
  • 31% of patients improved 2 or more CCS angina classes at 2 years.

REDUCER-I interim results

1

Verheye S, Jolicoeur EM, Behan MW, et al. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med 2015; 372: 519–527.

COSIRA Prospective Randomized

Beginning in 2010, Neovasc and clinicians worldwide began studying the safety and effectiveness of the Reducer* device. 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina and myocardial ischemia who were not candidates for revascularization were enrolled. One randomized group received the device (treatment group) while another received a sham procedure (control group). COSIRA demonstrated patients receiving the Reducer device achieved a statistically significant improvement in angina symptoms and quality of life compared to patients in a sham control group.2

  • 71% of patients improved 1 or more CCS angina classes at 6 months.
  • 35% of patients improved 2 or more CCS angina classes at 6 months.
  • Quality of life improved 17.6 points for patients who received the implant, vs. 7.6 points for patients in the control group.

COSIRA full results

2

Verheye, S., Jolicœur, E. M., Behan, M. W., Pettersson, T., Sainsbury, P., Hill, J., Vrolix, M., Agostoni, P., Engstrom, T., Labinaz, M., de Silva, R., Schwartz, M., Meyten, N., Uren, N. G., Doucet, S., Tanguay, J.-F., Lindsay, S., Henry, T. D., White, C. J., & Edelman, E. R. (2015). Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina. New England Journal of Medicine, 372(6), 519-527. https://doi.org/10.1056/nejmoa1402556.

*

COSIRA = COronary SInus Reducer for treatment of Refactory Angina

See the Impact for Patients*

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Jean’s Story

Jean, an active 80-year-old Londoner, had started becoming depressed as severe and increasingly untreatable angina negatively affected her quality of life. Her doctor recommended Reducer therapy, which helped Jean get her life back.

“If I want to go out, it doesn’t take me half an hour to get out of the house…my life is a lot more social now, and that stops you from being depressed… I’m just glad I had it done, and I would advise everybody else that has bad angina, if they’re offered (Reducer therapy), take it.”

– Jean, Reducer Patient

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Trevor’s Story

Trevor, a 59-year-old individual, began experiencing cardiovascular symptoms during his 30s, leading to his hospitalization on 24 separate occasions due to these issues. In February 2022, Trevor suffered from persistent angina, prompting his doctor to suggest Reducer therapy. This treatment not only alleviated his symptoms but also enhanced his overall activity level and quality of life.

“It is the best thing I’ve ever done. It’s improved my quality of life and I’m getting out and about and starting to move. That’s more than I could have asked for.”

– Trevor, Reducer Patient

ITN Business The Hidden Heart Shockwave Reducer Patient Highlight

Dipak's Story

In his 80s, Dipak, facing refractory angina, found relief with Reducer after conventional treatments failed. Climbing stairs once triggered heart attack-like symptoms, but now, post-implantation, he can ascend without pain. Previously at the end of the road with traditional approaches, Dipak's transformative experience brings a sense of freedom and joy:

"I can get up, and I don't have any pain. I feel really lovely about it. I feel free."

– Dipak, Reducer Patient

*Individual patient stories. Results may vary.

Reducer Resources

Reducer Spec Sheet thumbnail
Product Spec Sheet
View Sheet
shockwave reducer ifu
Instructions for Use
View Guide
Reducer Physician Brochure thumbnail
Reducer Brochure
View Brochure

Caution: In the United States, Reducer is an investigational device, limited by United States law to investigational use.

The Reducer is subject of Investigational testing and is being studied in the COSIRA-II trial in Canada.

The Reducer is commercially available in certain countries outside the U.S. and Canada. Please contact your local representative for specific country availability.

Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events: ifu.neovasc.com

EuroPCR 2023: Coronary Sinus Reducer - Insights Into Treating Refractory Angina Patients

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