CircuLite Inc. announced that it has received CE marking approval for the Synergy Circulatory Support System, a micro-pump designed to halt the progression of heart failure. By working with the heart’s native pumping capacity, Synergy is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management.

Abiomed Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella ventricular assist device (VAD) providing peak flows of approximately 4 liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD.

September 11, 2012 — St. Jude Medical Inc. announced the realignment of its product divisions into two new operating units: the Implantable Electronic Systems Division (IESD) and the Cardiovascular and Ablation Technologies Division (CATD).

The Abiomed Impella heart pump

September 11, 2012 — Primary results from an ongoing trial by Maquet Cardiovascular using intra-aortic balloon pumps (IABP) as an adjuvant treatment for myocardial infarction (MI) complicated by cardiogenic shock have shown no difference in patient survival when compared to standard care alone.

September 11, 2012 — Since the previous consensus document was published in 2007, catheter and surgical ablation of atrial fibrilliation (AF) have become standard treatments and more randomized trials of ablation versus optimal drug therapy for AF have been conducted. “Significantly more data exist on techniques, success rates and complications of these new interventions, making this a more valid document compared to 2007,” said Professor Karl Heinz Kuck of Germany, president-elect of the European Heart Rhythm Association (EHRA) and co-chair of the task force that developed the latest document.

September 11, 2012 — Data presented at the 2012 ESC Congress in Munich from the prospective DeFACTO study show that, when compared to standard coronary angiography, the noninvasive assessment of fractional flow reserve by computed tomography (FFR-CT) provides a more accurate determination of which lesions require invasive evaluation.

September 10, 2012 — Maquet Cardiovascular LLC announced 30-day results from the large, randomized, multicenter intra-aortic balloon pump (IABP)-SHOCK II clinical trial in patients with acute myocardial infarction (AMI) who were in cardiogenic shock and undergoing early revascularization. The findings showed that use of intra-aortic balloon counter-pulsation (IABC) therapy was associated with an observed improvement in all-cause mortality at 30 days, but the trial did not meet the pre-specified 12 percent improvement in survival endpoint compared with standard medical therapy.

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now