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April 30: The FDA issued a drug safety communication limiting the duration and usage of Samsca (tolvaptan) due to possible liver injury that may result in organ transplant or death. Due to recent clinical trial findings, the Agency warns that patients should not take the drug for longer than 30 days and it should not be used to treat patients with underlying liver disease. Samsca, a selective vasopression V2-receptor antagonist, is used to treat patients with clinically significant hypervolemic and euvolemic hyponatremia, including those with heart failure.
March 27: The FDA issued a Class I recall of Guardian II and Guardian II NC Hemostasis Valves (Model Numbers 8210, 8211, 8215, 8216) manufactured by Vascular Solutions Inc. The Agency notified health care professionals that serious adverse health consequences, including death, could occur due to the potential for an air embolism. Products that were manufactured and distributed between February 2012 and February 2013 are affected. Ahead of the FDA recall, Vascular Solutions sent an "Urgent Medical Device Recall" notice to its customers warning about the risk. Read the FDA alert.
March 26: The FDA rejected oral treprostinil, a prostacyclin vasodilator, for the second time for the treatment of pulmonary arterial hypertension. The Agency issued a complete response letter to United Therapeutics explaining the rejection. The drug is on the market in injectable and inhalable forms.
March 18: The FDA issued an alert regarding the recall of all products compounded by Med Prep Consulting, Inc. due to "lack of sterility assurance." While all lots of all products have been recalled, the alert stems from mold found in “50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution.” All facilities that have received products compounded by Med Prep Consulting have been contacted by the company and instructed to return products to the pharmacy. Read the full FDA safety alert.
March 12: The FDA issued a Drug Safety Communication announcement regarding the drug azithromycin (Zithromax or Zmax) warning that it may lead to potentially fatal irregular heart rhythm. According to the FDA announcement, patients who are more likely are those with “existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.” Read the FDA’s statement.
Feb. 25: The FDA approved BIOTRONIK's Lumax 740 DX System, a first-of-its-kind single-chamber implantable cardiac defibrillator with “atrial sensing capabilities.” This device allows for the detection of both ventricular and atrial rhythms. Read the press release.
Feb. 13: The FDA approved Medtronic’s Advisa DR MRI SureScan system, an MRI-safe second generation pacemaker system. To date, the first and second generation SureScan systems are the only pacemakers on the U.S. market that are MRI-approved. CMS will only cover MRIs in patients with these approved devices.
Feb. 13: The FDA issued a Class I recall of the St. Jude Medical AMPLATZER TorqVue FX Delivery System due to the possibility of the distal end of the core wire to "fracture when exposed to a combination of certain cardiac anatomies and usage conditions." Use of the system, used in conjunction with the Amplatzer Occluder devices, should be halted immediately. Read the FDA Safety Alert.
Feb. 13: The FDA granted 510(k) clearance to Paragonix for the Sherpa Pak Cardiac Transport System, which uses cold air and oxygenated perfusion to keep hearts alive during transport before transplants. While the system has the potential to keep hearts alive for up to 12 hours, three times the current standard, the FDA only approved the system for up to four hours initially. This approval marks the first advancement in the way donor hearts are transported in years and has the potential to increase the number of heart transplants performed in the U.S.
Jan. 29: The FDA approved mipomersen sodium (Kynamro), an injection that’s paired with lipid-lowering medications and diet for the treatment of homozygous familial hypercholesterolemia (HoFH). HoFH is an extremely rare condition that often causes heart attacks and even death in young patients. Kynamro is an orphan drug approval that is intended to treat fewer than 200,000 people. Read the FDA's statement.
Jan. 25: The FDA approved alogliptin (Nesina), a dipeptidyl peptidase-4 inhibitor, for the treatment of type 2 diabetes. Additionally, two combination drugs that include alogliptin were approved: alogliptin combined with metformin (Kazano) and alogliptin combined with pioglitazone (Oseni).
Jan. 10: An FDA advisory panel recommended approving canagliflozin (Invokana), a novel type 2 diabetes drug . Part of a class of SGLT2 inhibitors, the drug blocks blood glucose from being reabsorbed by the kidney, expelling it via urine. If approved, canagliflozin would be the first of its kind on the market. While the panel voted 10-5 in favor of approving the drug, several concerns were raised, including early cardiovascular events and stroke. Several panelists expressed the need for a cardiovascular outcomes study before the drug is approved. The decision will head to the FDA next.
Jan. 3: The FDA approved the XIENCE Xpedition(TM) Everolimus Eluting Coronary Stent System, which is particularily beneficial for patients with complicated coronary anatomies. The XIENCE stents, manufactured by Abbott, are currently the only stents approved for direct stenting in the U.S.
Dec. 28: The FDA has approved apixiban (Eliquis), an oral tablet used to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation (AFib) that is not caused by a heart valve problem. According to the FDA, the safety and efficacy of apixiban in treating patients with AFib not caused by cardiac valve disease were studied in the ARISTOTLE trial, a clinical trial of more than 18,000 patients that compared apixiban with the anti-clotting drug warfarin. In the trial, patients taking apixiban had fewer strokes than those who took warfarin. Apixiban joins other oral anticoagulants dabigatran and rivaroxaban, which have also been approved for this indication. According to the FDA, patients with prosthetic heart valves or with AFib caused by a heart valve problem should not use apixiban as these patients were not studied in a clinical trial. Read the complete FDA statement.
Dec. 20: The FDA released a safety communication warning against the use of dabigatran (Pradaxa) in patients with mechanical prosthetic heart valves. The warning stems from findings of a recently-halted European clinical trial (RE-ALIGN) that found a greater risk of strokes, heart attacks and blood clots in mechanical heart valve patients treated with dabigatran as compared to those taking the anticoagulant warfarin. Bleeding risk was also increased post-valve surgery in patients treated with dabigatran versus warfarin. The drug, an anticoagulant used to guard against stroke or blood clots in patients with non-valvular atrial fibrillation (AF), is not approved for patients with AF triggered by heart valve problems. Read the complete FDA alert.
Dec. 12: The FDA issued a warning stemming from the results of a meta-analysis of clinical trials that found a higher occurrence of major adverse cardiovascular events in patients who were prescribed varenicline (Chantix), a smoking cessation drug, compared to patients who were administered a placebo. However, the Agency noted that “these events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.” The FDA first warned of potential adverse events associated with varenicline in June 2011 and required the drug’s manufacturer to perform the meta-analysis. The drug’s label has been updated to reflect the findings of the meta-analysis. While quitting smoking greatly reduces the risk of cardiovascular disease, the FDA is advising health care professionals to carefully evaluate varenicline’s benefits and risks before prescribing the drug. Read the FDA’s alert.
Dec. 5: The FDA is warning health care professionals of potential QT interval prolongation associated with ondansetron hydrochloride (Zofran), 32 mg, single IV dose. The drug, used to reduce nausea and vomiting caused by chemotherapy, will no longer be marketed as a result of these cardiovascular risks.
Nov. 29: Atrovastatin Calcium Tablets, used to lower blood cholesterol, have been voluntarily recalled by Ranbaxy Inc. due to the possible presence of glass particles in the tablets. According to the FDA, “the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size)”. Due to the small size of the particles, it is not likely to cause safety hazards, however, 41 lots have been recalled out of precaution. Read the FDA safety alert.
Nov. 28: Certain lots of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes have voluntarily been recalled by Bracco Diagnostics, Inc. due to the presence of particulates. Due to the potential for adverse events, the FDA advises that health care professionals immediately discontinue use and “immediately quarantine product.” Read the FDA warning.
Nov. 20: The FDA approved the HeartWare Ventricular Assist System for heart failure patients who are awaiting transplant. Approval of the left ventricular assist device (LVAD), which is implanted next to the heart versus in the abdomen, was based on data from the ADVANCE trial that compared HeartWare patient outcomes to outcomes of patients affiliated with the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). This is the first time that registry data has been used to approve an LVAD. “For patients awaiting a donor heart, the HeartWare System provides a new treatment option,” noted Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. The FDA’s Circulatory System Devices panel recommended approving the device in April 2012.
Nov. 19: The FDA issued a Class I Recall for the HeartSine Samaritan Public Access Defibrillator 300/300P, due to reports of certain devices intermittently turning on and off, leading to complications with the battery. According to the FDA, the device, used to treat patients experiencing sudden cardiac arrest, may be “unable to deliver therapy during a cardiac event.” Read the full FDA safety alert.
Nov. 15: The FDA approved the first drug-eluting stent for use in patients with peripheral artery disease (PAD). The Zilver PTX Stent will expand treatment options for patients with PAD beyond the current options that include exercise, drug therapy, balloon angioplasty, bare-metal stenting or surgical bypass. According to Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, a clinical trial “demonstrated that the Zilver is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery.” Read the complete FDA statement.
Nov. 13: The FDA expanded the approved indications for the Valiant® Thoracic Stent Graft with the Captivia Delivery
System manufactured by Medtronic, Inc. The system is now approved for endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta, including treatment of blunt traumatic aortic injuries.
Nov. 8: The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of degludec (Tresiba), a long-lasting insulin product manufactured by Novo Nordisk. However, the panel also voted unanimously in favor of conducting a cardiovascular outcomes trial. The decision heads to the FDA next.
Nov. 2: The FDA approved expanded indications for rivaroxaban (Xarelto) to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as to reduce the risk of recurrent DVT and PE. Read the FDA’s statement.
Oct. 19: FDA statement on fungal meningitis outbreak includes cardioplegic solution warning.
Sept. 28: The FDA approved Boston Scientific Corporation’s S-ICD® System, a subcutaneous implantable defibrillator for the treatment of patients at risk for sudden cardiac arrest.
Sept. 20: The FDA granted 510(k) clearance for CVInsight, a device that uses a pulse wave to monitor a patient’s vital signs and cardiovascular health.
Sept. 19: The FDA issued a Drug Safety Warning for pramipexole (Mirapex), used to treat Parkinson's disease and restless legs syndrome, due to a possible increased risk of heart failure. Read more.
Sept. 13: The FDA's Cardiovascular and Renal Drugs Advisory Committee voted against approving lixivaptan for the treatment of hyponatremia for both congestive heart failure and syndrome of inappropriate antidiuretic hormone secretion. This decision will now head to the FDA.
Sept. 10: The FDA approved the BodyGuardian Remote Monitoring System, designed for patients with cardiac arrhythmias, for hospital and clinic use.
Sept. 10: The FDA granted 510(k) clearance to Abiomed for its Impella® CP™ (Cardiac Power) 4L/min heart pump, an enhanced version of the Impella 2.5 device.
Aug. 24: The FDA approved the Arctic Front Advance(TM) Cardiac Cryoballoon for the treatment of paroxysmal atrial fibrillation (AF). The second-generation system, manufactured by Medtronic, Inc., uses new technology that delivers coolant inside the balloon. The STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial concluded that cryoballoon ablation is safe and efficacious in the treatment of symptomatic AF, as compared with AAD alone. The system also received the Conformité Européenne Mark.
Aug. 17: The FDA approved the first generic version of pioglitazone (sold currently under brand name Actos) for treatment of type 2 diabetes. The drug is used as an adjunct to diet and exercise to control blood glucose levels. The FDA approved 15 mg, 30 mg and 45 mg tablets. Read more.
Aug. 16: The FDA issued a safety communication for recalled Riata and Riata ST implantable cardioverter defibrillator leads due to increased risk of premature insulation failure that can cause the lead to malfunction. The leads were recalled in November 2011. Additional information and recommendations are available from the FDA.
August 7: The FDA approved a stent system for the treatment of iliac artery disease. The Omnilink Elite Vascular Balloon-Expandable Stent System was approved following positive outcomes of the MOBILITY study.
July 27: The FDA approved the MultiHance® Injection (gadobenate dimeglumine ) for use in magnetic resonance angiography to evaluate patients with renal or aorto-ilio-femoral occlusive vascular disease. The injection was previously cleared for intravenous use in magnetic resonance imaging of the central nervous system in adults and children.
July 26: The FDA approved a new prescription fish oil formulation (Vascepa) for the treatment of high levels of triglycerides (TG). The drug is indicated as an adjunct to diet in adult patients with severe hypertriglyceridemia (TG > 500 mg/dL) who are at risk for stroke and heart attack. This is the second prescription fish oil pill to receive FDA clearance. Read more.
July 25: The FDA approved the CorPath 200 System, a robotic system used for percutaneous coronary interventions and manufactured by Corindus Vascular Robotics. The technology allows the surgeon to avoid high levels of radiation from x-rays while performing the procedure.
July 11: The FDA issued a Class I Recall of Alere Triage, a rapid diagnostic test system, used to diagnose heart failure and myocardial infarction and assess patients for pulmonary embolism. According to the FDA, “identified lots may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results.” Health care professionals should discontinue use of affected products and discard them immediately. Read more.
July 9: The FDA released a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids. According to the FDA Commissioner Margaret Hamburg, MD, "Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge. The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs." Read more.
June 27: The FDA approved the obesity drug lorcaserin, 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 FDA decision is expected around July 17.
June 25: The FDA has requested additional information from the manufacturers of apixaban, a factor Xa inhibitor, for the prevention of stroke in patients with atrial fibrillation. The agency has not requested additional trials, but would like further clarification from the ARISTOTLE trial that investigated the efficacy of apixaban versus warfarin in these patients.
June 13: The FDA granted 510(k) clearance to Cardiosolutions Inc.’s Dexterity™ Steerable Introducer, a next generation structural heart access introducer and delivery conduit.
June 4: The FDA granted 510(k) clearance to Hansen Medical, Inc. for its Magellan™ Robotic System for peripheral vascular interventions.
June 4: The FDA approved Boston Scientific’s 32 MM and 38 MM lengths for PROMUS ElementTM Plus Platinum Chromium Stent System. The PROMUS Element is the company’s next-generation drug-eluting stent technology for treating patients with coronary artery disease.
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.