Talk:Abiomed

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The Wikimedia Foundation's Terms of Use require that editors disclose their "employer, client, and affiliation" with respect to any paid contribution; see WP:PAID. For advice about reviewing paid contributions, see WP:COIRESPONSE. Uma Chandrasekaran (talk · contribs) has been paid by unknown.

This edit request by an editor with a conflict of interest has now been answered.

Should read Abiomed, rather than AbioMed— Preceding unsigned comment added by Amcan1850 (talk • contribs)

Done, but please see your talk page for advice about conflicts of interest.--ukexpat (talk) 17:26, 11 December 2013 (UTC)[reply]

Abiomed (Nasdaq: ABMD) produces breakthrough heart support technologies to enable more complete, minimally invasive procedures; heart muscle recovery; and cost-effective patient care. The company’s motto is: “Recovering Hearts. Saving Lives.”

Abiomed is the only company with FDA approval for a heart recovery ventricular assist device (VAD).

Based in Danvers, Massachusetts, Abiomed has approximately 500 employees worldwide, including 115 in Aachen, Germany and the EU.

Founded in 1981, Abiomed was run by then CEO David Lederman who led the development of the AbioCor, the World’s First Total Artificial Heart (1). The AbioCor device was used to replace the main pumping chambers in the human heart. Additional VADs were also developed, including the BVS5000® and the AB5000™, both short-term implantable devices that could support both sides of the heart and were used as a “bridge to recovery,” enabling a patient to receive hemodynamic support and have the opportunity to potentially recover the natural heart muscle or be eligible for a heart transplant.

Michael R. Minogue joined Abiomed in 2004, and as CEO, Chairman and President, he led the acquisition of Impella®, the World’s Smallest Heart Pump, which received FDA 510(k) clearance in 2008. The Impella can be inserted percutaneously through a small incision in the leg and threaded up to the heart where it can then help perform some or all of the pumping action of the heart. The Impella platform includes multiple products, all of which can be powered through the same console, called the Automated Impella Controller (AIC). The Impella pumps in the comprehensive product offering include the following:

Impella® 2.5 The Impella 2.5 is a percutaneous, catheter-based heart pump that pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta.

The pump can be inserted via a standard catheterization procedure (in the cath lab) through the femoral artery in the leg, into the ascending aorta, across the valve and into the left ventricle.

In June 2008, the Impella 2.5 received the following 510(k) clearance from the FDA: “intended for partial circulatory support using an extracorporeal bypass control unit for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.”

Impella CP™ The Impella CP™ is a new percutaneous, catheter-based Impella device. The increased flow of the Impella CP is delivered on the same platform as the Impella 2.5. The pump can be inserted through the same procedure as the Impella 2.5.

In September 2012, the Impella CP received the following 510(k) clearance from the FDA: “intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.”

Impella® 5.0 The Impella 5.0 catheter is an intravascular microaxial blood pump that delivers up to 5.0 liters per minute of forward flow blood from the left ventricle to the aorta.

The Impella 5.0 can be inserted into the left ventricle via a femoral cut down or through the axillary artery. The Impella 5.0 pump goes through the ascending aorta, across the valve and into the left ventricle.

In April 2009, the Impella 5.0 received 510(k) clearance from the FDA: “intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.”

Automated Impella® Controller (AIC) The Automated Impella Controller (AIC) is the primary user control interface for the Impella platform. The AIC controls the Impella catheter performance, monitors for alarms, and displays real time hemodynamic and catheter position information. The AIC is also approved for patients to be transported while being supported by the Impella.

Additionally, other Impella pumps are currently in research and development and are not yet approved by the FDA, including the following:

Impella® RP The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient's leg and deployed through the venous system, across the right side of the heart without requiring a surgical procedure. The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study (RECOVER RIGHT) and is not currently approved for sale in the United States. Impella® Pediatric Abiomed is in the process of developing the Impella Pediatric. The device will be helpful in treating infants and children with heart failure. This device has not been approved yet for sale or use in the United States.

Symphony™ Outside of the Impella platform, Abiomed has developed Symphony, a minimally invasive implantable heart pump designed to slow the progression of heart failure and help remodel the heart. The Symphony device is not cleared for sale or use in the United States and is currently being used in clinical investigations in Canada and France.

The Impella platform has been studied in numerous peer-reviewed publications.(2) A new milestone was reached in 2013 with physicans implanting more than 15,000 Impella pumps in U.S. patients (3). Additionally, more than 800 hospitals in the U.S. have the Impella pump in their catheterization labs or surgical suites.

In 2013, the U.S. Department of Veterans Affairs(4) made it easier for federal health care facilities to purchase the Impella when it awarded a contract to provide the Impella platform to military veterans at VA facilities, Dept. of Defense hospitals and other federal agencies. In 2013, the Boston Business Journal honored Abiomed as an Innovation All-Star. (5)

Abiomed reported fiscal year 2013 revenues of $157.61 million.(6) The figure represents a 25 percent increase over the previous fiscal year and a five-fold increase during Mr. Minogue’s tenure.

For fiscal 2012, Abiomed reported the first profitable year in its history. Net income was $1.5 million, or basic net income of 4 cents a share, on revenue of $125 million. For fiscal 2013, which ended March 31, 2013, net income was $15.01 million, or basic net income of 38 cents a share, on revenue of $157.6 million.

Veteran’s Work

CEO Minogue is a military veteran who served for four years on active duty in the U.S. Army and for eight years in the Army’s Individual Ready Reserve. Minogue served in Operation Desert Storm and earned multiple distinctions, including the Bronze Star. He is a 1989 graduate of the United States Military Academy at West Point.

Minogue helped found the Medical Technology Veterans Program (MVP), a year long career training and mentorship initiative designed to help veterans entering the civilian workforce transition into jobs in the medical device and diagnostic industries.(7) He currently serves as chairman of the program.

REFERENCES 1. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm077536.htm 2. http://www.ncbi.nlm.nih.gov/pubme d /19463408

http://www.ncbi.nlm.nih.gov/pubmed/22935569
http://www.ncbi.nlm.nih.gov/pubmed/22105829

3. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=782468

4. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=787071 5. http://www.bizjournals.com/boston/news/2013/10/04/bbj-names-innovation-all-stars.html 6. http://www.wikinvest.com/stock/ABIOMED_%28ABMD%29/Data/Income_Statement 7. http://www.medicaltechnologyveterans.org — Preceding unsigned comment added by MollyD543 (talk • contribs) 19:02, 10 January 2014 (UTC)[reply]

Abiomed (Nasdaq: ABMD) produces heart support technologies to enable more complete, minimally invasive procedures; heart muscle recovery. Abiomed is the only company with FDA approval for a heart recovery ventricular assist device(VAD). Based in Danvers, Massachusetts, Abiomed has approximately 500 employees worldwide, including 115 in Aachen, Germany and the EU. It was founded 1981 and then run by then CEO David Lederman. Lederman led the development of the AbioCor, the World’s First Total Artificial Heart (1). The AbioCor device was used to replace the main pumping chambers in the human heart. Additional VADs were also developed, including the BVS5000® and the AB5000™, both short-term implantable devices that could support both sides of the heart and were used as a “bridge to recovery,” enabling a patient to receive hemodynamic support and have the opportunity to potentially recover the natural heart muscle or be eligible for a heart transplant.

Michael R. Minogue joined Abiomed in 2004, and as CEO, Chairman and President, he led the acquisition of Impella®, the World’s Smallest Heart Pump, which received FDA 510(k) clearance in 2008. The Impella can be inserted percutaneously through a small incision in the leg and threaded up to the heart where it can then help perform some or all of the pumping action of the heart. The Impella platform includes multiple products, all of which can be powered through the same console, called the Automated Impella Controller (AIC). The Impella pumps in the comprehensive product offering include the following: Impella® 2.5 The Impella 2.5 is a percutaneous, catheter-based heart pump that pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta. The pump can be inserted via a standard catheterization procedure (in the cath lab) through the femoral artery in the leg, into the ascending aorta, across the valve and into the left ventricle. In June 2008, the Impella 2.5 received the following 510(k) clearance from the FDA: “intended for partial circulatory support using an extracorporeal bypass control unit for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.” Impella CP™ The Impella CP™ is a new percutaneous, catheter-based Impella device. The increased flow of the Impella CP is delivered on the same platform as the Impella 2.5. The pump can be inserted through the same procedure as the Impella 2.5. In September 2012, the Impella CP received the following 510(k) clearance from the FDA: “intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.” Impella® 5.0 The Impella 5.0 catheter is an intravascular microaxial blood pump that delivers up to 5.0 liters per minute of forward flow blood from the left ventricle to the aorta. The Impella 5.0 can be inserted into the left ventricle via a femoral cut down or through the axillary artery. The Impella 5.0 pump goes through the ascending aorta, across the valve and into the left ventricle. In April 2009, the Impella 5.0 received 510(k) clearance from the FDA: “intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.” Automated Impella® Controller (AIC) The Automated Impella Controller (AIC) is the primary user control interface for the Impella platform. The AIC controls the Impella catheter performance, monitors for alarms, and displays real time hemodynamic and catheter position information. The AIC is also approved for patients to be transported while being supported by the Impella. Additionally, other Impella pumps are currently in research and development and are not yet approved by the FDA, including the following: Impella® RP The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient's leg and deployed through the venous system, across the right side of the heart without requiring a surgical procedure. The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study (RECOVER RIGHT) and is not currently approved for sale in the United States. Impella® Pediatric Abiomed is in the process of developing the Impella Pediatric. The device will be helpful in treating infants and children with heart failure. This device has not been approved yet for sale or use in the United States. Symphony™ Outside of the Impella platform, Abiomed has developed Symphony, a minimally invasive implantable heart pump designed to slow the progression of heart failure and help remodel the heart. The Symphony device is not cleared for sale or use in the United States and is currently being used in clinical investigations in Canada and France. The Impella platform has been studied in numerous peer-reviewed publications.(2) A new milestone was reached in 2013 with physicans implanting more than 15,000 Impella pumps in U.S. patients (3). Additionally, more than 800 hospitals in the U.S. have the Impella pump in their catheterization labs or surgical suites. In 2013, the U.S. Department of Veterans Affairs(4) made it easier for federal health care facilities to purchase the Impella when it awarded a contract to provide the Impella platform to military veterans at VA facilities, Dept. of Defense hospitals and other federal agencies. In 2013, the Boston Business Journal honored Abiomed as an Innovation All-Star. (5) Abiomed reported fiscal year 2013 revenues of $157.61 million.(6) The figure represents a 25 percent increase over the previous fiscal year and a five-fold increase during Mr. Minogue’s tenure. For fiscal 2012, Abiomed reported the first profitable year in its history. Net income was $1.5 million, or basic net income of 4 cents a share, on revenue of $125 million. For fiscal 2013, which ended March 31, 2013, net income was $15.01 million, or basic net income of 38 cents a share, on revenue of $157.6 million. Veteran’s Work

CEO Minogue is a military veteran who served for four years on active duty in the U.S. Army and for eight years in the Army’s Individual Ready Reserve. Minogue served in Operation Desert Storm and earned multiple distinctions, including the Bronze Star. He is a 1989 graduate of the United States Military Academy at West Point. Minogue helped found the Medical Technology Veterans Program (MVP), a year long career training and mentorship initiative designed to help veterans entering the civilian workforce transition into jobs in the medical device and diagnostic industries.(7) He currently serves as chairman of the program.

REFERENCES 1. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm077536.htm 2. http://www.ncbi.nlm.nih.gov/pubme d /19463408 http://www.ncbi.nlm.nih.gov/pubmed/22935569 http://www.ncbi.nlm.nih.gov/pubmed/22105829 3. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=782468 4. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=787071 5. http://www.bizjournals.com/boston/news/2013/10/04/bbj-names-innovation-all-stars.html 6. http://www.wikinvest.com/stock/ABIOMED_%28ABMD%29/Data/Income_Statement 7. http://www.medicaltechnologyveterans.org — Preceding unsigned comment added by MollyD543 (talk • contribs) 19:02, 10 January 2014 (UTC)