Technology | Ventricular Assist Devices (VAD) | April 02, 2018

FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor

Technology updates allow real-time visualization of key hemodynamic data directly on the Impella console

FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor

April 2, 2018 — Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. The company said these advances in technology and software are designed to improve productivity, ease of use and patient management to ensure optimal patient care.

The addition of Impella CP with SmartAssist includes the following features:

  • Simplified patient management: Advanced software and new optical sensor improves understanding of real-time, exact positioning for the Impella heart pump and allows for repositioning without the need for imaging equipment;
  • Integration of clinical data informatics on Impella console: Real-time informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP) and cardiac power output (CPO) provides optimal support for patients; and
  • Ease of use: Faster setup with fewer steps and connections simplifies patient management for physicians, cath lab staff and ICU staff. New steps further reduce start time by 15 percent, which is critical for emergency patients in cardiogenic shock.

Abiomed has already received CE marking approval in the European Union to market Impella CP with SmartAssist. To date, over 60 patients at three sites have been treated with Impella CP with optical sensor. Abiomed submitted more than 60 engineering reports and full technical specifications for this expanded PMA approval, which were approved by the FDA. To date, the clinical data informatics has been tested on the Abiomed Impella Controller on 38 patients at two hospitals in the U.S.

Over the next fiscal year, Abiomed will launch the Impella CP with SmartAssist through a controlled roll-out at hospital sites with established heart recovery protocols. A simple upgrade to Abiomed’s existing installed base will be performed on the routine service cycle.

“The ability to view fundamental hemodynamic data such as LVP, EDP and CPO directly on the Impella console provides critical information for clinical decision-making,” said William O’Neill, M.D., medical director, Center for Structural Heart Disease, Henry Ford Hospital. “Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU.”

The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the ability to enable native heart recovery, allowing patients to return home with their own heart.

The Impella 2.5, Impella CP and Impella CP with SmartAssist, devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries.

Abiomed's right-side heart pump, the Impella RP device, is FDA-approved to treat patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

For more information:

Related Impella Content

FDA Expands Impella Indication for High-risk PCI Procedures

Abiomed Receives Expanded Impella Approval for Cardiomyopathy With Cardiogenic Shock

VIDEO: Editor's Choice of the Most Innovative New Technologies at TCT 2017

Detroit Cardiogenic Shock Initiative Goes National at TCT 2017

VIDEO: Overview of the National Cardiogenic Shock Initiative

Related Content

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init