Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony
Reporter: Aviva Lev-Ari, PhD, RN
Abiomed (NASDAQ: ABMD) is a pioneer and global leader in healthcare technology and innovation, with a mission of RECOVERING HEARTS AND SAVING LIVES. Abiomed CEO, Chairman, and President, Michael R. Minogue, has focused the company’s efforts on developing ground-breaking technologies designed to assist or replace the life-sustaining pumping function of the failing heart. The Company’s portfolio of products and services offer healthcare professionals an array of choices across a broad clinical spectrum. From the world’s first total replacement heart to the World’s Smallest Heart Pump, 1/100th the size of the heart with rapid and simple insertion, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.
http://www.abiomed.com/about/about-abiomed/
Quick Facts
Company founded in 1981
Corporate Headquarters: Danvers, Massachusetts
European Division: Aachen, Germany
Number of Employees: 400+
NASDAQ Symbol: ABMD
Only company with FDA approval for heart recovery
First and only World’s Smallest Heart Pump
First Total Artificial Heart
Abiomed Announces Record Fourth Quarter Revenue of $37.3 Million, Up 31% and Achieves Profitability for Full Fiscal Year |
DANVERS, Mass., May 16, 2012 (GLOBE NEWSWIRE) — Abiomed, Inc. (Nasdaq:ABMD – News), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2012 revenue of $37.3 million, up 31% compared to revenue of $28.5 million in the same period of fiscal 2011, and GAAP net income of $2.6 million or $0.06 per diluted share compared to GAAP net loss of $1.8 million or a loss of $0.05 per basic and diluted share in the prior year. For the full fiscal year, total revenue was $126.4 million, up 25% compared to revenue of $101.2 million in the prior fiscal year and GAAP net income was $1.5 million or $0.04 per diluted share compared to GAAP net loss of $11.8 million or a loss of $0.32 per basic and diluted share in the prior year. |
http://phx.corporate-ir.net/phoenix.zhtml?c=95629&p=irol-newsArticle&ID=1696354&highlight=
SYMPHONY – SYNCHRONIZED WORLD SMALLEST HEART PUMP ASSIST DEVICE [Symphony is not approved for use]
- Promotes myocardial recovery/remodeling
- Partial circulatory support device
- Avoids issues with continuous full flow devices: GI bleeding, aortic valve dysfunction
Why Infraclavicular Fossa?
- Most common site for device placement
- Avoids thoracotomy/ sternotomy
- Access to “central” circulation via subclavianartery
- Previous or future sternotomiesnot an issue
DESIGN & OPERATION
- An implantable, synchronized assist device
- Placement in pacemaker pocket
- Single graft to subclavianartery
- Synchronized with subcutaneous EKG leads:Afterload reduction-Decreased LV work, Increases Cardiac Output, Increases coronary and systemic blood flow, Decreases filling pressure
- Device output: 3.0 L/min at 100 bpm
PRODUCT POSITIONING
Meets goals for a less invasive, cost-effective partial assist device designed for recovery:
Improves hemodynamics, may improve QOL
Simple implantation, (No thoracotomy or sternotomy) -Pacemaker pocket
Simple device design, less costly/cost effective
Potential to optimize heart failure medications or future therapies (stem cell, pharma)
Designed to promote recovery with future explant (Promotes native heart recovery/remodeling with intent to explant)
Allows for short LOS and home discharge
Limitations of current Heart Failure Therapy – Progression of disease impacts patient’s QOL
Prognosis poor with advanced heart failure
Limited heart transplant availability
Implantable LVADs require major operation, long hospitalizations, readmissions and are costly
No current implantable cardiac assist device has been designed for heart recovery/remodeling
- Early studies showed efficacy-NIH funding
- Over 90 bovine implants and 25 cadavers in development process
- Validated final device design
- Successful GLP pre-clinical study completed
- Ready for First in Man experience
SYMPHONY PRE-CLINICAL IMPLANTS
Bovine model with anastomosisto carotid artery
- Mimics position in human implants
- Initial studies showed efficacy in bovine heart failure model
- Final GLP studies prior to first-in-man implants (n=6) 30 day implants, Warfarin(INR 2x baseline), anti-platelet therapy, full autopsies
CURRENT PRODUCT PORTFOLIO
Impella 5.0 Axillary Insertion
Impella 5.0 Cut Down Insertion
REFERENCES on Importance of Cardiac Power Output (CPO)
Fincke R, Hochman JS, Lowe AM, et al. Cardiac Power Is The Strongest Hemodynamic Correlate of Mortality in Cardiogenic Shock: A Report From the SHOCK Trial Registry. J Am Coll Cardiol 2004;44(2):340-8
den Uil CA, Lagrand WK, van der Ent M, et al. Impaired Microcirculation Predicts Poor Outcome Of Patients With Acute Myocardial Infarction Complicated By Cardiogenic Shock. Eur Heart J 2010;31(24):3032-39
Mendoza DD, Cooper HA, Panza JA. Cardiac Power Output Predicts Mortality Across A Broad Spectrum Of Patients With Acute Cardiac Disease. Am Heart J 2007;153:366-70
Torre-Amione G, Milo-Cotter O, Kaluski E, et al. Early Worsening Heart Failure In Patients Admitted For Acute Heart Failure: Time Course, Hemodynamic Predictors, And Outcome. J Card Fail 2009;15(8):639-44
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Open Journals vs. Subscription-based « Pharmaceutical Intelligenceâ, very compelling plus the blog post ended up being a good read.
Many thanks,Annette