Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED 3/24/2013
Abiomed Facing Reclassification of Heart Pump Medical Device
MARCH 18, 2013 / MEDICAL DEVICE BLOG
Reclassification can often be a stressful and expensive process for medical device manufacturers. The recent case of Abiomed, and reclassification of its Impella 2.5 cardiac assist pump, is an example of the consequences of regulatory shift after a product has already been launched on the market.
The Impella 2.5 example is one that has been borne out of the FDA’s initial willingness to make an exception for nonroller cardiovascular blood pumps. Although technically a Class III device, a regulatory exemption created an opportunity for this type of product to avoid the rigors of the pre-market approval process and instead be marketed via 510(k). The basis of the exemption had to do with Abiomed assuring the agency that its pump was similar to other nonroller-type pumps.
Unfortunately for the company, a recent FDA advisory panel (the Circulatory System Devices Panel) reviewed the exemption (in place since 2008) and recommended that the Impella 2.5 lose its Class III 510(k) status. This decision was made after a careful examination of the changing standards for medical device approval over the course of the last five years.
What does this mean for Abiomed? The reclassification will require that the company provide the FDA with specific information proving the safety and efficacy of the Impella 2.5 device. Abiomed is not optimistic about the potential to demonstrate the benefits of its product to the satisfaction of the agency, especially after a previous study did not offer a compelling argument in favor of the pump. The company has 18 months to complete the work required to gather the needed data to support a PMA. Sales of the pump can continue until the PMA is either accepted or rejected.
Abiomed shares lower as FDA panel votes to retain Class III status for Impella
December 7, 2012 11:30 am by Paul Quintaro,
Abiomed, Inc. (Nasdaq: ABMD) last night announced that the U.S. FDA Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella®. The 515i Reclassification Panel’s confirmation of this category of device as Class III devices is consistent with both the current Class III classification for these device types and as recommended in the FDA’s briefing documents, released on December 3, 2012.
“We would like to thank the 515i Panel and FDA for their time and consideration, as well as Dr. Jeffrey Popma of Beth Israel Deaconess Medical Center and Dr. William O’Neill of Henry Ford Hospital, who highlighted the compelling body of clinical evidence supporting Impella, including the PROTECT II data set,” said Michael R. Minogue, President, Chairman and Chief Executive Officer, Abiomed. “We look forward to collaborating with the FDA on next steps and agree with the 515i Panel’s feedback that our existing data, combined with our U.S. registry, position us to work with the FDA to submit a PMA application. We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients.”
The FDA’s 515i program is designed to review all previously 510(k) cleared Class III devices and determine the appropriate controls to ensure safety and effectiveness for the intended use of these product categories. The classification of Impella as a Class III device requires Pre-Market Approval (PMA) controls (versus prior 510(k) Class III special controls) to ensure safety and effectiveness in the intended use. As per the 515i Reclassification Process and confirmed by the FDA Panel, products will remain on the market for a sufficient period to allow for manufacturers to submit and the FDA to review Pre-Market Approval applications.
As per the statues of the 515i program, there is no change to the current 510(k) clearance for Impella throughout the remaining steps of the reclassification process for Non-Roller Type Cardiopulmonary Bypass Pumps. Following yesterday’s Panel recommendation, the next steps in the 515i process include FDA issuance of a Proposed Final Order, followed by a period of public comment, FDA issuance of a Final Order, and then submission of Pre-Market Approval applications by manufacturers with devices in the category. Throughout this series of reclassification steps, Abiomed will continue to market the Impella family of heart pumps and looks forward to working with FDA to submit the necessary clinical data under the PMA application process.
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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