Abiomed Responds to MedSun Report on Two Impella Pumps

Editor's note: This story has been updated from the original story to include comments from Abiomed. A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. However, the company told MD+DI that the information in the MedSun report is inaccurate. According to the report, which is located here on FDA's website, one Impella pump reportedly had an unknown "material" inside the pump, causing it to have flows "less than expected," and another pump's housing/outlet cage and impeller were somehow crushed and the device did not start. Abiomed claims that the pumps did not malfunction. "The first pump worked exactly as it was supposed to – a clot was detected in the patient’s bloodstream and a safety mechanism triggered, shutting down the pump, so the clot did not go to the patient’s brain.  The second pump was damaged during the insertion process," said Tom Langford, director of communications and public relations at Abiomed. MedSun is an adverse event reporting program launched in 2002 by FDA's Center for Devices and Radiological Health (CDRH). The way the program works is participants use an Internet-based system that is designed to serve as an easy and secure way to report adverse medical device events. The agency says the primary goal for MedSun is t...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news

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Int J Angiol DOI: 10.1055/s-0038-1676369The Impella device is a catheter-based miniaturized ventricular assist device. Using a retrograde femoral artery access, it is placed in the left ventricle across the aortic valve. The device pumps blood from left ventricle into ascending aorta and helps to maintain a systemic circulation at an upper rate between 2.5 and 5.0 L/min. This results in almost immediate and sustained unloading of the left ventricle, while increasing overall systemic cardiac output. The most common indications for using the Impella device are in the treatment of acute myocardial infarction complicated by ca...
Source: International Journal of Angiology - Category: Cardiology Authors: Tags: Review Article Source Type: research
CONCLUSIONS Mitochondrial damage is a potentially important mechanism and early indicator for 5-FU-induced cardiovascular disease. PMID: 30240386 [PubMed - in process]
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
Conclusions: The identified LV and RV mechanic changes appear to support interventricular hemodynamic dependence during TTC, which may represent a universal rescue mechanism in a jeopardized or injured heart. PMID: 29997970 [PubMed]
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
CONCLUSION: Prolonged veno-arterial extracorporeal life support for cardiac failure is feasible with low technical complication rates. Survival rates are acceptable, yet inferior to short-term support. We observed a shift from initial shock-related complications to infections during prolonged support. Since recovery and thus weaning is rather unlikely after a prolonged need for extracorporeal life support, this form of support should be limited to centers offering the full spectrum of interdisciplinary cardiac care including ventricular assist device implantation and transplantation. PMID: 29896993 [PubMed - as supplied by publisher]
Source: The International Journal of Artificial Organs - Category: Transplant Surgery Authors: Tags: Int J Artif Organs Source Type: research
One of our graduates, Rochelle Zarzar, who is now an education fellow, sent me this from one of the hospitals she works at now:An elderly woman presented with chest pain.  She had been nauseous the night before and did not feel well, then awoke 2 hours prior with chest pain.She had had a completely normal angiogram 3 months prior.Here is that angiogram report:The left main coronary artery is normal.Left anterior descending is a type 3 vessel and is normal.Left circumflex is nondominant and normal.The right coronary artery is dominant and normal.The nurses immediately recorded an ECG.  This was 2 hours after the o...
Source: Dr. Smith's ECG Blog - Category: Cardiology Authors: Source Type: blogs
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy. The approval follows a previous FDA indication the Danvers, Mass.-based company won in April 2016 that cleared the device for treating acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock. Abiomed touts its Impella heart pumps as the only percutaneous temporary ventricular support ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news
I was reading through ECGs on the system when I saw this one:Sinus tachycardia, rate 120Computerized QTc = 380 msWhat do you think? I was immediately worried about a proximal LAD occlusion.  Although sinus tachycardia generally argues against ACS, a large anterior MI may result in such poor stroke volume that there is compensatory tachycardia and possibly impending cardiogenic shock. I looked to see if there was an ED cardiac ultrasound, and there was:Parasternal Long Axis:Poor image, but one can see that there is poor apical functionParasternal short axis:This shows poor contractility of the anterior wall.C...
Source: Dr. Smith's ECG Blog - Category: Cardiology Authors: Source Type: blogs
Conclusion Despite hemodynamic improvements with IABP support, patients with non-AMI cardiogenic shock still suffer poor outcomes. Patients with ischemic cardiomyopathy and low LVPCI fared significantly worse. These patients may warrant closer observation or earlier consideration of more advanced hemodynamic support.
Source: American Heart Journal - Category: Cardiology Source Type: research
ConclusionLevitronix Centrimag ® remains a versatile device with potential in an acute setting. Early aggressive treatment and a younger patient population may well justify its use.
Source: Indian Journal of Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
You're reading Is it Possible to Die from a Broken Heart?, originally posted on Pick the Brain | Motivation and Self Improvement. If you're enjoying this, please visit our site for more inspirational articles.   Falling in love is one of the most beautiful and exciting feelings in the world. We need only to think of our beloved partner and our heart skips a beat. We are full of energy and plans for the future. Yet what about when the romance dies? What happens to our heart then? Anyone who’s been properly lovesick knows how painful it is to feel so lovelorn, so sad, and so worthless. It seems to us that our lo...
Source: PickTheBrain | Motivation and Self Improvement - Category: Consumer Health News Authors: Tags: featured happiness health and fitness popular reading best books best health books best self-improvement blogs broken heart can you die from a broken heart cardiac love mental health pickthebrain stress wellness Source Type: blogs
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