Indications for Use

Daniel Lenihan, MD
“It’s one thing to detect the problem; it’s another to manage it better. So, that’s the real frontier that we want to tackle. We don’t just want to identify a problem; you want to manage it better so that these patient scan still get the best cancer therapy that they may be eligible for, [and] at the same time, protect their heart over the course of this treatment.” 

[Reference] How cardiovascular magnetic resonance may help cancer patients. ESC Council Webinar. 2020.

"MyoStrain is the first test that provides physicians with the inherent visibility to monitor the effects of cardiotoxicity from cancer therapy and promote the use of cardio-protective drugs on the heart. This is a game-changing technology that could revolutionize how we carefully monitor patients undergoing cancer treatment.”

[Reference] New PROACT Study to Evaluate MyoStrain in the Detection & Management of Cardiotoxicity in Cancer Patients

“MyoStrain provides a way to follow chemotherapy patients, identifying those that are beginning to develop toxicity and…give them medication that will hopefully improve their cardiac reserve and you see a responsive change on the MRI measurements.”

[Reference] Global Cardio-Oncology Summit 2018.

Sebastian Kelle, MD, PhD
“The Congress has been very successful in creating awareness for MyoStrain, which could become the new standard in cardiac function testing in patients with risks of heart failure. Its speed, ease and accuracy makes the test very patient-centric. Patients want to have an accurate functional assessment of their heart."

[Reference] Hauptstadt Congress 2019.

“This new sensitive cardiac function test (MyoStrain) potentially opens numerous unmet markets because the test could be used not only to quantify early cardiac dysfunction but also in aiding physicians to manage drug therapies. Over time, recurring testing enables physicians to understand the effects of therapies to individualize care.”

[Reference] Myocardial Solutions Receives FDA 510(k) Clearance for MyoStrain

“MyoStrain provides a quantitative, single-heartbeat MRI test that allows us to detect patient heart risk without radiation or contrast injections, and may therefore offer a proactive, patient-centric tool to effectively detect and manage patients at risk of heart failure.”

[Reference] Korosoglou G, et al. J Am Coll Cardiol Cardiovasc Imaging. Jan 13, 2021. DOI: 10.1016/j.jcmg.2020.10.024

Grigorios Korosoglou, MD
"Through its progressive curve, MyoStrain helps clinicians to not only determine a patient’s risk of developing heart failure, but to individualize care as well by monitoring the effectiveness of treatment on the patient overtime. This may allow clinicians to focus on preventing the progression of heart dysfunction early on for improved clinical outcomes and quality of life for patients.”

[Reference] Steen H, et al. J Cardiovasc Magn Reson23, 45(2021).

“MyoStrain was able to both identify and classify cardiac risk in patients who did not exhibit any cardiovascular symptoms and where traditional metrics could not. These are substantial findings that could profoundly impact the standard of care in cardiology and cardio-oncology.”

[Reference] Korosoglou G, et al. J Am Coll Cardiol Cardiovasc Imaging. Jan 13, 2021. DOI: 10.1016/j.jcmg.2020.10.024

Susan Dent, MD
“MyoStrain bridges a crucial gap in oncology and cardiology care. Thanks to the advances in oncology care, cancer is more treatable now than ever before. While clinical outcomes for cancer patients have improved, there is increasing concern about the potential short- and long-term side effects of these treatments, including the potentially detrimental impact they may have on the heart."

[Reference] Guisca S, et al. Circulation. 2021;14:e012459

“The cases I have shown you today, I think, clearly show that MyoStrain certainly may help oncologists in clinical decision making…hopefully, as further information comes into practice, we will be able to use this technology to help us make decisions around the delivery of cancer care safely to our patients”

[Reference] Virtual Cardio-Oncology Summit 2020.

Teresa López-Fernández, MD
“With MyoHealth, we are able to minimize the scan time and minimize the analysis time…This new cardiac MRI technique allows us to better implement cardiac MRI in our daily practice”

[Reference] Virtual Cardio-Oncology Summit 2020.

Henning Steen, MD, PhD
"Utilizing [MyoStrain] measurements in clinical practice could aid physicians in identifying individual patients who potentially benefit from proactive cardioprotective therapy even before the onset of cardiotoxicity."

[Reference] Geršak B, et al. Predicting the severity of subclinical chemotherapy-induced cardiotoxicity using Fast-SENC segmental myocardial strain— An interim report (NCT03543228). (SCMR 2019).

“[MyoStrain] could be a paradigm shift in imaging for MRI, so that we have the tools to risk stratify asymptomatic patients and also the progression of [dysfunction] measurements.”

[Reference] MyoStrain Detects Early Subclinical Pathological Intramyocardial Dysfunction ahead of Current Imaging Modalities (Hamburg Registry)

“MyoStrain offers the visibility needed to help clinicians assess early asymptomatic dysfunction in our patients. It uses a unique and highly sensitive technique to acquire segmental strain, which provides us both the ability to detect and subsequently categorize these patients into risk groups based on the individual patterns and severity of their dysfunction.”

[Reference] Steen H, et al. J Cardiovasc Magn Reson 23, 45(2021).

“MyoStrain can divide patients into healthy patients, at-risk patients, pre-heart failure and heart failure patients based on the percentage of normal myocardium segments.”

[Reference] Global Cardio-Oncology Summit 2018.

“[MyoStrain has] good reproducibility, excellent applicability, segmental circumferential data that is not captured by echocardiograms, very fast, simple CMR protocols, you can do four patients per hour, very sensitive to myocardial deformation and changes, no contrast agents, arrhythmia independent and vendor independent.”

[Reference] Global Cardio-Oncology Summit 2018.

“Door to door, from when the patient enters the facility to when he/she leaves, it takes 22 minutes. So with less than 15 minutes of scan time, you can do four patients per hour."

[Reference] Global Cardio-Oncology Summit 2018.

“MyoStrain [detects] the reduction of circumferential and longitudinal strain when feature tracking does not.”

[Reference] Global Cardio-Oncology Summit 2018.

Deborah Kwon, MD
"[MyoStrain] holds promise for identifying patients early in their myocardial disease trajectory who are at risk for declining contractility over time and may benefit from early therapeutic intervention."

[Reference] Cardiac MRI: 7 New and Emerging Developments to Be Aware Of. Cleveland Clinic. 2021.

Marco Ochs, MD
"The hyperventilation/breath-hold maneuver combined with MyoStrain/MyoStress provides a fast and safe scan procedure for clinicians to assess their patients without needing contrast agents or pharma stressors. The result is a 15-minute, needle-free MyoStress test designed to help advance ischemia detection, improve workflow efficiency and enhance the overall patient experience.”

[Reference] Ochs M, et al. J Am Coll Cardiol Cardiovasc Imaging. Apr 14, 2021. DOI: 10.1016/j.jcmg.2021.02.022

Valentina Püntmann, MD
“Prior to cancer-related treatment, Cardiac MRI is helping us in recognizing pre-existing conditions, risk assessment of patients, and also guiding prevention of patients at risk of heart failure during or post-CR-treatment.  For this we need standardized, accurate and validated tools, allowing us to detect small differences on the individual basis. MyoStrain is an excellent candidate to deliver this."

[Reference] How cardiovascular magnetic resonance may help cancer patients. ESC Council Webinar. 2020.

Matthias Friedrich, MD
“There are numerous limitations concerning the safety, feasibility, logistical effort, and speed with today’s stress testing techniques. We adapted the hyperventilation/breath-hold maneuver with MyoStrain to help overcome these limitations, providing a fast, safe and non-invasive approach to improve the cardiovascular assessment of patients suspected of coronary artery disease. This is a huge step.”

[Reference] Ochs M, et al. J Am Coll Cardiol Cardiovasc Imaging. Apr 14, 2021. DOI: 10.1016/j.jcmg.2021.02.022

Lauren Baldassarre, MD
"MyoStrain is a promising technology to help ensure cardiac health in patients receiving potentially cardio-toxic cancer therapies.”

[Reference] New PROACT Study to Evaluate MyoStrain in the Detection & Management of Cardiotoxicity in Cancer Patients

“MyoStrain has the potential to overcome the barriers of cardiac MRI availability and complexity."

[Reference] Global Cardio-Oncology Summit 2018.

Amit Patel, MD
“Changes in circumferential and longitudinal strain during intermediate-dose dobutamine infusion by [MyoStrain] can unmask CAD prior to the development of any quantifiable alteration in wall thickening by cine-CMR”

[Reference] Kawaji K, et al.  Detection of regional wall motion changes that precedes wall thickening using Strain-Encoded (SENC) CMR with intermediate-dose Dobutamine stress. SCMR 2019. (n=29)

Ronald Mikolich, MD
“The ability to evaluate progression of LV strain abnormalities with [MyoStrain] may help identify changes in LV function before the onset of a reduction in LVEF and development of heart failure”

[Reference] Kulifay S, et al. Detection of Sub-clinical Left Ventricular Dysfunction in Obese Patients. AHA Scientific Sessions 2018.

“The ability to identify and quantify abnormal left ventricular GLS and GCS with [MyoStrain] also opens the door to assess any benefit of therapy, including diet, exercise and bariatric surgery”

[Reference] Kulifay S, et al. Detection of Sub-clinical Left Ventricular Dysfunction in Obese Patients. AHA Scientific Sessions 2018.

United States & Europe

MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.

A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.

View FDA 510k >>

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Regulatory Disclaimer

MyoStrain is a diagnostic tool intended to be used together with a patient’s medical history and clinician’s professional judgement. MyoStrain has received FDA-clearance, CE-mark certification and is commercially available in the United States and Europe. Rx only.