Cardiology Product Guide » FDA

Medtronic Integrity Coronary Stent Gets FDA Approval

admin — Thu, 23 Sep 2010 06:35:31 +0000

The FDA has approved Medronic’s Integrity Coronary Stent System, based on an advanced biomedical engineering called continuous sinusoid technology, enabling the exploration of other new device concepts, such as a polymer-free drug-filled stent. The stent is said to feature a new, more flexible construction which is easier for surgeons to insert. A stent is a metal mesh which is placed inside an artery after it has been cleared of blockage.

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CorMatrix Receives FDA IDE Approval To Begin Prospective, Randomized Evaluation Of New Onset Postoperative Atrial Fibrillation

admin — Mon, 13 Sep 2010 05:01:01 +0000

CorMatrix Cardiovascular, Inc. announced that FDA has granted conditional approval for the start of a multi-center, randomized clinical trial to demonstrate the safety of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures and will be compared to subjects who do not undergo pericardial closure.

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FDA Recommends Dropping Low Blood Pressure Drug Midodrine Hydrochloride

admin — Tue, 24 Aug 2010 13:38:32 +0000

FDA Recommends Dropping Low Blood Pressure Drug – Midodrine Hydrochloride (ProAmatine) the FDA has recommended withdrawing the approval of ProAmatine (midodrine hydrochloride), a Shire Development Inc. medication for the treatment of orthostatic hypotension – a temporary drop in blood pressure (hypotension), usually due to suddenly standing up; when standing up the patient becomes dizzy or faints. The FDA says that post-approval studies that verify the clinical benefit of the medication have not been done.

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FDA Approves First Generic Blood Thinner Enoxaparin Sodium Injection

admin — Mon, 26 Jul 2010 05:02:44 +0000

The U.S. FDA (Food and Drug Administration) announced it has approved the 1st generic version of enoxaparin sodium injection (Lovenox), an anti-coagulant (blood thinner) used for the prevention of DVT (deep vein thrombosis), as well as some other therapies. Lovenox is made from heparin and was approved for use in the USA in 1993. It is a blood-thinning medication whose active ingredient is a naturally-derived complex mixture of sugar molecules.

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FDA Issues Class I Recall for Physio-Control’s LifePak 20/20e Defibrillators

admin — Wed, 07 Jul 2010 18:46:57 +0000

The Food & Drug Administration has slapped Medtronic Inc’s subsidiary Physio-Control Inc. with a Class I recall of its LifePak 20/20e defibrillators after the company declared a “field correction” for a battery problem last week. Physio-Control issued a “field correction” on July 2, after discovering that some of the devices might lose battery power while in operation.

FDA Approves Expansion of Endologix’s Main Product Line

admin — Wed, 07 Jul 2010 18:40:52 +0000

Endologix Inc said that the Food and Drug Administration has approved the expansion of its main product line. The FDA approval covers 31 new sizes of its Powerlink stents, which it said should expand the number of patients they can be used on by to 5% to 10%. Endologix’s stents are used to reinforce a ruptured or ballooning section of an artery.

Biosense Webster Gets FDA Clearances For The CartoXPress(TM) Software Module And Lasso(R) NAV Catheter For Its Carto(R) XP System

admin — Mon, 28 Jun 2010 14:25:50 +0000

Biosense Webster, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing the CartoXPress™ Software Module and the Lasso® NAV Circular Mapping Catheter for use with the Carto® XP Mapping System. These two new innovations provide electrophysiologists who do not have access to the Carto® 3 System, the company’s latest revolutionary 3D Mapping technology, with increased speed and efficiency in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms.

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FDA Urgently Recalls AED Battery

admin — Fri, 11 Jun 2010 20:06:04 +0000

The maker of a battery pack used in automated external defibrillators (AEDs) voluntarily recalled more than 5,000 of its units due to potentially fatal errors it causes in devices charged with the battery. The FDA has labeled the recall class I, reflecting the most severe warning and meaning that the affected device has a high probability of causing serious adverse events or death with use.

FDA Looking Into Heart-Related Death Risk of Benicar

admin — Fri, 11 Jun 2010 19:13:20 +0000

The FDA is looking into whether Daiichi Sankyo’s blood pressure medicine Benicar increases the risk of heart-related death. The regulatory body said it is evaluating data from a pair of clinical trials in which diabetes patients taking the drug, known chemically as olmesartan, had a higher rate of death from heart related causes compared with patients taking a placebo. In addition to reviewing data from the two studies, the FDA said it is considering additional ways to assess the cardiovascular effects of Benicar.

FDA okays expanded offering of Powerlink stent graft products

admin — Fri, 11 Jun 2010 18:19:53 +0000

Endologix Inc, a medical device maker, said it has received approval from the US regulatory authority to market an expanded offering of its Powerlink stent graft products. Powerlink, which is an already approved endovascular stent graft, is used in the treatment of abdominal aortic aneurysm. In abdominal aortic aneurysm, the aortic wall weakens, creating a “ballooning” of the blood vessel.