Abiomed (ABMD) Announces Launch if IQ Assurance Program

October 31, 2016 7:04 AM EDT
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Abiomed, Inc. (Nasdaq: ABMD) announced its Impella Quality (IQ) Assurance Program. The mission of the program is to improve real-world outcomes in Protected PCI and cardiogenic shock patients through training, education and utilization of clinical guidelines, protocols and best practices derived from observational quality assurance data (IQ), IRB approved registry data (cVAD) and IDE approved FDA studies.

These data resources include Abiomed’s IQ Database, which is a collection of observational quality assurance data on over 95% of Impella patients since the Impella 2.5™ heart pump’s introduction to the United States in 2008. Today, this holds more than 44,000 Impella case entries. This IQ database, combined with additional clinical data collected in the cVAD Registry™ and FDA pre- and post-market studies, has helped identify best practices and protocols that are linked to the highest survival and native heart recovery rates at the Impella hospitals. For example, the placement of Impella prior to doing a PCI in cardiogenic shock appears to improve outcomes.

We are sharing this with hospitals around the country as part of our comprehensive education and training initiatives with the goal of positively affecting both survival and recovery outcomes for this very high-risk patient population. Abiomed has invested more than $85 million in creating this collection of real-world evidence that is now being shared with our customers at no additional cost.

The goal of the IQ Program is to also complement these best practices with Abiomed’s clinical field team, consisting of over 250 individuals in the United States. This experienced team, which includes physicians and nurses, has expertise in hemodynamic support and provides 24x7 onsite clinical assistance from the cath lab to the Intensive Care Unit (ICU). The company also provides 24x7 call center support staffed by experienced cardiac nurses and technologists. From an educational perspective, Abiomed has created case-based learning tools and reinforces guideline-based appropriate use treatment. The program also encourages the use of After Action Reviews, which is a continuous learning tool that hospital Heart Teams can implement to improve practices after each case. In addition, the appropriate use rationale includes seven society guidelines for the use of pVADs, supported by a compendium of resources on improved outcomes and cost effectiveness.

“Abiomed has created the largest high-risk PCI and cardiogenic shock database of real-world evidence with different levels of analysis from observational quality assessment, to IRB prospective registries, to FDA prospective randomized studies,” said Michael R. Minogue, Abiomed President, Chairman and Chief Executive Officer. “We believe that by sharing our data-driven insights and clinical expertise, we can help hospitals create protocols, processes, and best practices to improve outcomes in Protected PCI and cardiogenic shock around native heart recovery.”

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