Posts Tagged ‘FDA approvals’

February 25th, 2014

FDA Approves New Catheter for Treatment of Atrial Fibrillation

The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in patients with drug-resistant paroxysmal atrial fibrillation (AF), sustained monomorphic ischemic ventricular tachycardia, and type I atrial flutter. The device is manufactured by Biosense Webster, a Johnson & Johnson company. The device, according to the company, “is the first therapeutic catheter approved in the […]

October 25th, 2013

FDA Approves Abbot’s MitraClip for Patients at Prohibitive Surgical Risk

The FDA today approved Abbott’s catheter-based MitraClip device for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. The company said it would launch the device immediately in the United States. The device is the first percutaneous nonsurgical therapy approved for the treatment of mitral valve disease. Surgery remains the option […]

October 23rd, 2013

FDA Approves First New Atherectomy Device in 20 Years

The FDA on Tuesday granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS  was the first new coronary atherectomy system to receive FDA approval in two decades. The company said it would begin a controlled launch of […]

January 29th, 2013

FDA Approves Mipomersen for Homozygous Familial Hypercholesterolemia

The FDA said today that it had granted approval to the novel cholesterol-lowering drug mipomersen sodium for use as an adjunct to diet and drug therapy in patients with homozygous hypercholesterolemia. The drug, which was developed by Isis Pharmaceuticals, will be marketed under the brand name of Kynamro by Genzyme. Kynamro was approved as an orphan drug, which the […]

November 15th, 2012

FDA Approves Zilver PTX Drug-Eluting Stent for Peripheral Arterial Disease

The FDA today approved Cook Medical’s Zilver PTX stent. It is the first drug-eluting stent (DES) approved for the treatment of peripheral arterial disease (PAD) in the superficial femoral and proximal (i.e., above the knee) popliteal artery. The new stent will provide a new treatment option for patients with PAD. Current treatments include exercise, drug […]

September 28th, 2012

Subcutaneous ICD Gains FDA Approval

The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) System from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and therefore does not need to be guided by X-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage […]

September 10th, 2012

Selections from Richard Lehman’s Literature Review: September 10th

This week’s topics include the safety risks of drugs that have gone through the FDA’s expedited approval program, a Framingham Heart Study paper on aortic stiffness in the elderly, and using CMR to detect previously undetected MI in older adults.

June 27th, 2012

FDA Approves a New Weight Loss Drug, Breaking a 13-Year Drought

The FDA announced today that it has approved its first new weight loss drug in 13 years. Lorcaserin, which will be sold under the brand name of Belviq, is manufactured by Arena Pharmaceuticals and will be distributed in the U.S. by Eisai. Lorcaserin is indicated for use in obese adults (BMI 30 or above), or overweight […]

June 26th, 2012

Unlikely PARTNERs Support TAVR

The FDA approval of TAVR and the design of postmarketing surveillance involved a remarkable degree of collaboration and cooperation among the stakeholders. What to do while we wait for data to accumulate?

June 25th, 2012

FDA Once Again Delays Approval of Apixaban (Eliquis)

The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two companies reported that […]