May 18: The FDA approved Boston Scientific Corporation’s Epic™ Vascular Self-Expanding Stent System used to widen iliac arteries and increase blood flow to the leg in patients with atherosclerosis. Read more from the FDA.
May 14: The FDA has issued 510(k) clearance to MAQUET Cardiovascular LLC for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. The larger catheters will enable clinicians to provide patients with increased hemodynamic support, regardless of their height.
May 10: An outside panel of experts advised the FDA to approve the obesity drug lorcaserin. A final FDA decision is expected around June 27. If approved, lorcaserin will be the first prescription weight-loss pill to be approved in the last decade. Earlier this year, an FDA advisory panel endorsed Qnexa, a similar drug and a final decision is expected before or on July 17.
May 9: The FDA has approved Sorin Group's Paradym RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices. These new devices, including the single-chamber PARADYM™ RF VR, the dual-chamber PARADYM™ RF DR and the PARADYM™ RF CRT-D, are designed to be monitored remotely. Meanwhile, BIOTRONIK also received FDA approval for its new Lumax 740 series of ICDs and CRT-Ds.
May 7: The FDA has approved three pacemakers manufactured by Boston Scientific: the INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-P). The first implant of the INGENIO pacemaker in the U.S. was performed on May 3 by Bruce L. Wilkoff, MD, FACC, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic.
“Matching the patient’s need to increase their heart rate with their precise activities is the main goal of cardiac pacing,” said Wilkoff, who is also president of the Heart Rhythm Society. “Achieving that match depends on having the right tools such as an MV sensor and intelligent programming.”
May 2: The FDA has approved a new device for treating Peripheral Artery Disease (PAD) in below the knee (BTK) vasculature. The technology is described as combining the functionality of a balloon angioplasty device with the addition of built-in embolic capture.
April 26: An FDA advisory panel announced support of a new type of implantable heart defibrillator that Cameron Health Inc. is developing for patients at risk of sudden cardiac arrest from an abnormal heartbeat. The FDA will make a final decision in the future.
April 25: An outside panel of experts advised the FDA to back the HeartWare ventricular assist device (HVAD) for use in patients with severe heart failure, but stressed the need for additional safety trials if approved. A final FDA decision will be made at a later date.
April 24: Roche Diagnostics Operations issued an “urgent medical device removal” to its Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays customers due to the potential for falsely low results in certain plasma samples that may lead to adverse health consequences. Customers were asked to immediately stop use of lots 163176 and 163177.
April 20: The FDA is under pressure from consumer advocacy group Public Citizen to pull Victoza (liraglutide) from the market on the basis that the type 2 diabetes drug increases the risk of thyroid cancer, pancreatitis, serious allergic reactions, and kidney failure. Novo Nordisk, the drug’s manufacturer, rejects Public Citizen’s claims and stressed that it continues to work closely with the FDA to ensure patient safety.
April 20: TomTec Imaging Systems GmbH received FDA 510(k) clearance for its 2D Cardiac Performance AnalysisMR software solution, an innovative model for analyzing myocardial deformation from routine CMR images. TomTec’s Vice President of Clinical Products and Innovations explained, “2D CPA MR provides incremental information regarding left ventricular deformation and enhances the diagnostic possibilities. With 2D CPA MR, even a comprehensive strain analysis can be fully integrated into your clinical routine workflow.”
April 20: The FDA alerted healthcare professionals of the potential risks of using aliskiren containing blood pressure medications along with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBS) in patients with diabetes or kidney impairment. Aliskiren containing drugs will undergo a label change to reflect the warning. Medications impacted include, Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide); Tekturna (aliskiren hemifumarate); Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide); Tekamlo (aliskiren hemifumarate and amlodipine besylate); and Valturna (aliskiren hemifumarate and valsartan). Read the complete FDA alert here.
April 20: Following discussions with the FDA, GilenyaR (fingolimod), used to treat patients with relapsing forms of MS, will undergo a label change indicating patients should receive an electrocardiogram (ECG) prior to initiating the drug as well as after the six-hour first-dose observation period. Additionally, blood pressure and heart rate should be monitored hourly and overnight monitoring is recommended for patients with certain pre-existing cardiac conditions. GilenyaR is contraindicated in patients who have undergone a heart attack or stroke within six months, experience cardiac rhythm disturbances, or are treated with certain anti-arrhythmic drugs. The label change provides detailed guidance on initiation and re-initiation of GilenyaR for health care providers.
April 17: The FDA has given Pluristem Therapeutics, Inc. clearance to initiate a Phase II Clinical Trial to evaluate PLX-PAD for the treatment of Intermittent Claudication (IC), a subset of Peripheral Artery Disease. The trial will evaluate the safety and efficacy of Pluristem's allogeneic cell therapy, a potential preventive treatment for IC.
March 16: The FDA approved an Investigational Device Exemption Supplement for HeartWare to enroll a fourth allotment of 54 patients in its "ADVANCE" bridge-to-transplant clinical trial. The trial is evaluating the HeartWare® Ventricular Assist System for patients with end-stage heart failure.
March 1: The FDA has delayed a decision on Eliquis by three months until June 28. Eliquis is an anticlotting drug from Bristol-Myers Squibb and Pfizer used to prevent strokes in people with atrial fibrillation. The FDA will use the additional time to review new clinical trial information provided by the two companies.
Feb. 22: The FDA has approved the Absolute Pro® Vascular Self-Expanding Stent is a thin, flexible metal mesh tube that is implanted in the iliac arteries. Read more.
Jan. 23: The FDA has approved the Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter, a steerable, deflectable, irrigated catheter used to treat typical atrial flutter. Read more.