New Drug Coated Stent Approved by FDA

Search

Topics

Uncategorized

Links
- FDA

Case Review Form

* Denotes required field.

Title

* First Name

* Last Name

* Email Address

* Phone Number

Cell Phone Number

Office Phone Number

Street Address

Apartment/Suite

City

State

Zip Code

Please provide the best method and times to contact you:

Date of birth of injured person
(mm-dd-yyyy):

Name of medical device:

Please describe any problems or injuries caused by the device:

Other Info:

No Yes, I agree to the Parker & Waichman, LLP disclaimers.Click here to review all.

Yes, I would like to receive the Parker & Waichman, LLP monthly newsletter, InjuryAlert.

Archives

Latest Medical Device News

20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP - Recall of one lot due to possible incorrect bar code for 5% Dextrose Injection, USP. The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication.
Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences - Recall issued because the devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.
Greenline-D MacIntosh No. 3 Laryngoscope Blades - Class 1 recall due to potential for piece of blade to break off during procedure.
Healon D Ophthalmic Viscosurgical Device - Recall of one lot of the product because some of the tested OVD syringes had endotoxin levels above the required limit.
Hydromorphone HCl 2 mg Tablets - Nationwide recall of a single lot due to potential for oversized tablets.
Innohep (tinzaparin sodium injection) - [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency
October 2008 Safety Labeling Changes - Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) - Reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products.
Stryker Custom Cranial Implant Kits - Class 1 recall because sterility cannot be assured.
Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae - Worldwide recall involving 21 lot codes, due to reports of difficulty retracting the introducer from the cannula.
Weight Loss Pills - Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.

New Drug Coated Stent Approved by FDA

July 8th, 2008 amy

Despite fears that drug coated stents can do more damage than good in many cases, the FDA has approved yet another drug coated stent — this one called Xience, manufactured by Abbott. This is the fourth drug coated stent to receive FDA approval.

In many cases, drug coated stents do save lives — or at least prolong them. In other cases, drug coated stents cause dangerous blood clotting and death. In December of 2006, the American Journal of Medicine published a study which found dangerous blood clotting to be 4-5 times more likely to occur in patients implanted with drug coated stents than with the older bare metal stents. Since that type, many doctors reverted back to using the bare metal stents except in cases where the benefits of using drug coated stents outweighed the risks.

Share and Enjoy: These icons link to social bookmarking sites where readers can share and discover new web pages.