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MADIT-CRT trial - How will it impact the ICD/CRT market

September 1, 2009

Analysis of:Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events (MADIT-CRT trial) | content.nejm.org

The MADIT CRT trial evaluated the benefit of cardiac resynchronization therapy for patients with reduced ejection fraction and mild cardiac symptoms. Previous studies have shown a benefit of CRT for patients with more severe cardiac symptoms. The trial demonstrated a significant reduction in the composite endpoint of heart failure events and death from CRT therapy. The of benefit was in the heart failure events component of the combined endpoint (as opposed to the mortality component).

remote monitoring will assist with tele-medicine in the field of arrhythmias

May 11, 2007

Analysis of:Remote Patient Monitoring and Disease Management Solutions Key to Promoting Growth in U.S. Tele-Health Solutions Market | sev.prnewswire.com

Remote monitoring is one of the most important areas of development in the field of cardiac arrhythmias and will play an important role in the field of tele-medicine. The applies to the cardiac rhythm management market as well as the diagnostic market. In the field of cardiac rhythm management, all three of the major U.S. device manufacturers (Medtronic, St. Jude, Boston Scientific) have remote monitoring technology. In field of arrhythmia diagnostics, remote monitoring continues to develop, whether is may soon be applied to implantable loop recorders (such as the Medtronic REVEAL device) or wearable holter monitors that can transmit data wirelelessly to the physician, this area of remote monitoring is also an essential part of modern patient management.

Predicting sudden death risk with T-wave alternans testing: The ALPHA study reported at the 2007 ACC meeting

March 30, 2007

Analysis of:Prognostic Value of T-Wave Alternans in Patients with Heart Failure Due to Nonischemic Cardiomyopathy: Results of the T-Wave Alternans in Patients wit | acc07.acc.org

The Prognostic Value of T-Wave Alternans in Patients with Heart Failure Due to Nonischemic Cardiomyopathy: Results of the T-Wave Alternans in Patients with Heart Failure (ALPHA) Study demonstrative a high negative predictive value for sudden cardiac death in patients with non-ischemic cardiomyopathy and a reduced ejection fraction.

In the study, a patient with a negative T-wave alternans test had less than 2% likelihood of experiencing a major endpoint within the first 18 months of follow-up.

This may suggest a lack of benefit of ICD therapy in this particular patient group. Further data randomized controlled trials may be needed to change clinical practice.

Atrial Fibrillation Ablation - Is High Frequency Ultrasound the Answer?

March 5, 2007

Analysis of:ProRhythm Initiates U.S. Pivotal Trial For HIFU Ablation System | www.medcompare.com

1. Atrial fibrillation ablation is one of the fastest growing procedural areas in cardiac electrophysiology.

2. There is a need to achieve a higher success rate than is currently being observe.

3. The majority of afib ablations are performed using radiofrequency energy.

4. Other ablation technologies include cryoablation (freezing) and microwave ablation.

5. The "focus-AF" trial will explore the ability of IFU technology to treat atrial fibrillation with a HIFU catheter placed via the femoral (leg) vein.

6. If this trial is positive, it could provide an important step to commercialization of this product.

Implantable hemodynamic monitoring for heart failure patients: Not ready for prime time

March 5, 2007

Analysis of:FDA Panel Rejects Medtronic Device To Monitor Hearts | online.wsj.com

1. The chronicle device is a stand alone hemodynamic monitor that is implanted in a similar fashion as a pacemaker. It includes a wire that is capable of measuring blood pressure in the lungs. This pressure measurement may serve as a early warning of worsening heart failure.

2. This hemodynamic monitor can also be designed to be part of an implantable defibrillator.

3. If hemodynamic monitoring, bundled with an implantable defibrillator, were deemed to be beneficial in heart failure patients, this could lead to an expansion of volume in an implantable cardiac rhythm device market that has recently experienced a slowing of growth.

4. This finding by the FDA reflects the fact that there is currently not enough data to support the use of this technology. More studies are in progress and there continues to be significant interest in technologies that assist with remote hemodynamic monitoring.

cardiome phase IIa pilot study results

November 14, 2006

Analysis of:http://cardiome.com/wordpress/?p=321 | cardiome.com

Similar efficacy of other antiarrhythmic drugs with less side effects. This is a small study and larger numbers are needed to make more definitive statements. See interpretation below.

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