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Percutaneous Heart Pumps Gain New Indications
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Abiomed announced the FDA approved four of its percutaneous heart pumps for treatment of HF associated with cardiomyopathy leading to cardiogenic shock, and two of its pumps for use in patients with severe CAD, extensive comorbidities and complex anatomy with or without depressed ejection fraction who are undergoing high-risk PCI procedures.
All four pumps (Impella 2.5, Impella CP, Impella 5.0 and Impella LD) were previously approved to treat acute MI with cardiogenic shock and post-cardiotomy cardiogenic shock. The two pumps with the new ejection fraction-related indication (Impella 2.5 and Impella CP) had been indicated only for those with depressed ejection fraction among patients with CAD or complex anatomy.
The pumps can now be used in patients with cardiomyopathy, including peripartum and postpartum cardiomyopathy and myocarditis resulting from isolated left ventricular failure that does not respond to other treatments, according to the company.
“With this approval, physicians now have a new FDA-approved treatment option for patients in cardiogenic shock caused by cardiomyopathy,” Cindy L. Grines, MD, FSCAI, chair of cardiology at the Zucker School of Medicine at Hofstra and Northwell Health, told Cardiology Today’s Intervention. “Impella devices offer the entire heart team, consisting of interventional cardiologists, HF specialists and heart surgeons, a minimally invasive treatment option that can be implanted through the femoral artery or via the subclavian artery in a short time frame, which avoids the need for a sternotomy.”
Regarding the ejection fraction-related indication, Ehtisham Mahmud, MD, FACC, FSCAI, chief of cardiovascular medicine, director of Sulpizio Cardiovascular Center-Medicine, director of interventional cardiology and cardiac cath lab and professor of medicine at UC San Diego School of Medicine, said in a press release that “this expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned down for surgery with severe coronary artery disease.”
The company also announced the launch of a new Women’s Initiative focusing on heart recovery education and awareness in conjunction with the new cardiomyopathy indication. – by Dave Quaile
- For more information:
- Cindy L. Grines, MD, can be reached at cgrines@northwell.edu.
Disclosures: Grines reports she has served on an advisory board for Abbott Vascular and receives speaking honoraria from Abiomed. Mahmud reports he has financial ties with Abbott Vascular/St. Jude Medical, Corindus and Medtronic.