Refractory Angina Treatment | Neovasc Reducer™ | Coronary Sinus | Angina

Reducer Overview
Reducer Product Details
CCS Angina Scores

Overview

The Neovasc Reducer™ provides treatment for patients with refractory angina. Refractory angina patients have severe, debilitating chest pain due to insufficient blood supply to the heart muscle that is not amenable to revascularization. The Reducer is implanted in the coronary sinus percutaneously using a simple catheter-based procedure and has been clinically demonstrated to provide significant relief of angina pain in these patients. There are approximately 1,000,000 new patients each year in the US and Europe with recurrent angina who either cannot be revascularized or who are otherwise poorly managed using conventional therapies. These patients represent an annual market opportunity of over $3B based for the Reducer product. The initial target market for the Reducer product is “no option” patients presenting with refractory angina. Once physicians have adopted Reducer for use in these refractory patients, it is expected that there will be a natural spillover into the broader recurrent angina market which represents a substantially larger patient population.

Product Details

The Neovasc Reducer is an hourglass shaped, balloon expandable, stainless steel “stent like” device, which is implanted in the coronary sinus, creating a restriction in venous outflow from the myocardium. It is implanted using conventional percutaneous techniques, typically via an internal jugular vein approach. The Reducer is provided sterile and pre-loaded on a balloon catheter system. The system is 9F sheath compatible and operates over a .035” guidewire. The implantation procedure is quick and requires minimal training. Once guidewire access to the coronary sinus is achieved, implantation typically takes less than 10 minutes.

Figure 1 – (a) Reducer System (b) Balloon and Reducer during expansion (c) Expanded Reducer after balloon is withdraw

Following implantation, the bare metal Neovasc Reducer endothelializes and creates a permanent (but reversible) narrowing in the coronary sinus. The coronary sinus is narrowed from a typical diameter of 10-12mm to approximately 3mm at the site of implantation. This narrowing slightly elevates the venous outflow pressure which restores a more normal ratio of epicardial/endocardial blood flow within the ischemic territories of the heart muscle. This results in improved perfusion of the endocardium relieving ischemia. The physiological mechanism behind this effect is well documented in medical literature.¹²³

The Neovasc Reducer has demonstrated excellent results in multiple animal studies and in a clinical trial of 15 patients suffering from chronic refractory angina, followed out to three years after implantation. The six month results from this clinical trial were published in the Journal of the American College of Cardiology ⁴ and three year data is being compiled and submitted for publication presently. Click the link to read the Neovasc press release: Neovasc Announces Positive Preliminary Clinical Results for its Reducer Product in Refractory Angina. In the clinical trial, implantation of the Reducer resulted in significant clinical improvements in stress test and perfusion measurements as well as an overall quality of life improvement in the majority of the patients.

Average CCS (Canadian Cardiovascular Society) angina score for the patients in the study dropped from 3.07 +/- 0.44 at baseline to 1.73 +/- 0.85 at six months with additional improvement confirmed at three years following Reducer implantation. There were no complications or adverse events related to the device.

Figure 2 – CT scan of implanted Reducer in coronary sinus of patient after three years.

Figure 3 - Perfusion echo images of ischemic heart pre- and post-implantation of Reducer. Porcine model, ischemia created with ameroid constrictor surgically implanted on the left circumflex artery. (a) Image demonstrates severe ischemia in upper right quadrant 30 days after ameroid constrictor implanted (b) The same animal six weeks later after a Reducer was implanted demonstrating normal perfusion in the previously ischemic region.

$Stress Perfusion image in refractory angina patient at baseline... The same patient six months after implantation of Reducer$

Figure 4 – (a) Stress Perfusion image in refractory angina patient at baseline demonstrating a 20cm²defect size (b) the same patient six months after implantation of Reducer patient demonstrates marked improvement in perfusion with a defect size of only 11cm²and significant improvement in angina symptoms.

CCS Angina Scores

Class I
Angina with strenuous, rapid, or prolonged exertion (Ordinary physical activity such as climbing stairs does not provoke angina.)

Class II
Slight limitation of ordinary activity (Angina occurs with postprandial, uphill, or rapid walking; when walking more than two blocks of level ground or climbing more than one flight of stairs; during emotional stress; or in the early hours after awakening.)

Class III
Symptoms with everyday living activities, i.e. moderate limitation. Marked limitation of ordinary activity (Angina occurs with walking 1-2 blocks or climbing a flight of stairs at a normal pace.)

Class IV
Inability to perform any activity without angina or angina at rest, i.e. severe limitation.

References

Click here for references.

The Neovasc Reducer is protected by issued US/International patents and related applications.

Reducer is in a pre-commercial stage and is not available for sale.


Figure 1 – (a) Reducer System (b) Balloon and Reducer during expansion (c) Expanded Reducer after balloon is withdraw

		Following implantation, the bare metal Neovasc Reducer endothelializes and creates a permanent (but reversible) narrowing in the coronary sinus. The coronary sinus is narrowed from a typical diameter of 10-12mm to approximately 3mm at the site of implantation. This narrowing slightly elevates the venous outflow pressure which restores a more normal ratio of epicardial/endocardial blood flow within the ischemic territories of the heart muscle. This results in improved perfusion of the endocardium relieving ischemia. The physiological mechanism behind this effect is well documented in medical literature.¹²³ The Neovasc Reducer has demonstrated excellent results in multiple animal studies and in a clinical trial of 15 patients suffering from chronic refractory angina, followed out to three years after implantation. The six month results from this clinical trial were published in the Journal of the American College of Cardiology ⁴ and three year data is being compiled and submitted for publication presently. Click the link to read the Neovasc press release: Neovasc Announces Positive Preliminary Clinical Results for its Reducer Product in Refractory Angina. In the clinical trial, implantation of the Reducer resulted in significant clinical improvements in stress test and perfusion measurements as well as an overall quality of life improvement in the majority of the patients. Average CCS (Canadian Cardiovascular Society) angina score for the patients in the study dropped from 3.07 +/- 0.44 at baseline to 1.73 +/- 0.85 at six months with additional improvement confirmed at three years following Reducer implantation. There were no complications or adverse events related to the device.
Figure 2 – CT scan of implanted Reducer in coronary sinus of patient after three years.

Figure 3 - Perfusion echo images of ischemic heart pre- and post-implantation of Reducer. Porcine model, ischemia created with ameroid constrictor surgically implanted on the left circumflex artery. (a) Image demonstrates severe ischemia in upper right quadrant 30 days after ameroid constrictor implanted (b) The same animal six weeks later after a Reducer was implanted demonstrating normal perfusion in the previously ischemic region.
$Stress Perfusion image in refractory angina patient at baseline... The same patient six months after implantation of Reducer$
Figure 4 – (a) Stress Perfusion image in refractory angina patient at baseline demonstrating a 20cm²defect size (b) the same patient six months after implantation of Reducer patient demonstrates marked improvement in perfusion with a defect size of only 11cm²and significant improvement in angina symptoms.

CCS Angina Scores
Class I	Angina with strenuous, rapid, or prolonged exertion (Ordinary physical activity such as climbing stairs does not provoke angina.)
Class II	Slight limitation of ordinary activity (Angina occurs with postprandial, uphill, or rapid walking; when walking more than two blocks of level ground or climbing more than one flight of stairs; during emotional stress; or in the early hours after awakening.)
Class III	Symptoms with everyday living activities, i.e. moderate limitation. Marked limitation of ordinary activity (Angina occurs with walking 1-2 blocks or climbing a flight of stairs at a normal pace.)
Class IV	Inability to perform any activity without angina or angina at rest, i.e. severe limitation.