Global Therapeutics Receives CE Mark Approval For Advanced GTX® Bare Metal Coronary Stent System Designed For Optimal Clinical Performance

Global Therapeutics, cardiology unit of Cook Medical, has received CE Mark approval for a new cobalt chromium bare metal coronary stent that company executives believe will fill a demand for non-drug eluting coronary stents among interventional cardiologists, company announced today. The device, Global Therapeutics GTX® Coronary Stent System, is available immediately in the European Union and United Kingdom.

" Ever since the issue of late-stage thrombosis associated with drug-eluting coronary stents ( DECS ) came to light recently, interventional cardiologists have been re-examining valuable role bare metal stents can play in treating coronary artery disease in many patients, " explained Joe Horn, president of Global Therapeutics.

" Not only do our bare metal stents eliminate concerns associated with potential delayed reactions from DES in certain coronary patients, our bare metal cobalt chromium stent has advanced features designed to improve clinical performance of BMS in coronary arteries. The GTX stent has been engineered specifically to eliminate the technical challenges, such as recoil, stent balloon retention and stent spring-back, that have been associated with earlier cobalt chromium stent designs currently on the market. "

In addition to these technical advantages, Horn added, GTX may offer a significant cost-savings. Bare metal versions of coronary stents historically cost about one-third as much as their drug-coated iterations, making bare metal stents a more cost-effective option in treating many coronary disease patients.

" This device fills a real need at a time when health care systems around world are struggling to contain skyrocketing healthcare costs for heart disease, leading killer in the industrialised world, " Horn said. " Not every coronary patient truly needs a drug-eluting stent, and we feel GTX platform offers a significant advance in bare metal stent technology many cardiologists and hospitals will welcome both for its potential clinical benefits and for its cost-effectiveness. "

Global Therapeutics also is developing a breakthrough drug-eluting stent ( DES ) technology using GTX platform and an improved application of antisense gene therapy-developed by its partner, AVI BioPharma, Inc. ( NASDAQ: AVII: http: //www. avibio. com ) of Corvallis, Oregon-to inhibit the proliferation of a gene known to induce restenosis process, Horn added. The clinical trial is expected to begin in third quarter of 2008 in Europe.

About Cook Medical

Cook Medical was one of first companies to help popularise interventional medicine, pioneering many of devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of prestigious Medical Device Manufacturer of Year Award from Medical Device & Diagnostic Industry magazine.

Cook Medical

Healthcare recommendations for woman and man

Modern medicine: Diazepam.

uses of Diazepam

Diazepam is used to treat episodes of increased seizures ( e. g. , acute repetitive seizures, breakthrough seizures ) in people who are already taking medications to control their seizures. Diazepam is only recommended for short-term treatment of seizure attacks. It's not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious ( possibly fatal ) seizures that do not stop ( status epilepticus ) .

Diazepam belongs to a class of medications called benzodiazepines which produce a calming effect on brain and nerves ( central nervous system ) . It is thought to work by increasing the effect of a certain natural chemical ( GABA ) in brain.

how to use of Diazepam

Read the Patient/Caregiver Information Leaflet provided by your pharmacist before you use Diazepam and each time we get a refill. If we have questions, consult your doctor or pharmacist.

Diazepam is given rectally by a caregiver trained to recognize the symptoms of your seizures and to correctly give product. You and your caregivers must follow all instructions from your doctor and pharmacist exactly. Review all instructions on how to give Diazepam in product package. If you have any questions or feel unsure about using Diazepam, call the doctor or pharmacist before using Diazepam. Get emergency help if person is having a seizure and we do not feel comfortable using Diazepam.

Before using, check syringe for the correct dose. Your pharmacist should set correct dose and lock the syringe in " ready " position before giving we product. Before leaving pharmacy, look at each syringe. The dose should be in display window on side. We should see a green band with the word " ready " at the bottom of the syringe barrel. Look to make sure you have correct syringe tip ( e. g. , smaller tip for a child ) and that there are no cracks around syringe tip. Return product to pharmacist if there's a problem or if you have any questions

Cracks can cause medication to leak out and not provide correct amount of medication. If we see a crack, use a different syringe. Cracks can appear over time, so keep checking your syringes to make sure we have good ones ready to use. Also check expiration date on package, and refill your prescription before medication expires.

The dosage is based on age, weight, medical condition, and response to therapy. Be sure we understand when Diazepam should be used, how to use it, and how to check for side effects/seizure control. In some cases, a second dose may be prescribed and given 4 to 12 hours after the first dose. Usually, Diazepam should not be used to treat more than 5 episodes per month and no more than one episode every 5 days. If seizures continue after using Diazepam as prescribed ( e. g. , no change 15 minutes after dose is given ) , or if there's a change in person's breathing, behavior, or condition that alarms you, get emergency help right away.

Diazepam should not be used regularly. This medication may cause dependence when it has been used regularly for a long time ( more than a few weeks ) or if it has been used in high doses. In such cases, if you suddenly stop Diazepam, withdrawal reactions may occur while use Diazepam. Such reactions can include increased seizures. Report any such reactions to your doctor immediately. When stopping extended, regular treatment with Diazepam, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though it's very unlikely to occur, Diazepam can also result in abnormal drug-seeking behavior ( addiction/habit forming ) . Do not increase your dose, take it more frequently, or use it for a longer time than prescribed.

Dispose of Diazepam properly. Follow directions in Patient Information Leaflet. Do not reuse the syringe.

Don't stop taking your regular seizure control medications when we are given Diazepam.

side effects of Diazepam

Drowsiness, dizziness, diarrhea, and unsteadiness may occur. If these persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed Diazepam because he or she has judged that the benefit to we is greater than risk of side effects. Many people using Diazepam don't have serious side effects. Diazepam stays in body for a long time. Be sure to watch for reactions for at least 4 hours after giving the medication.

Seek immediate medical attention if any of these unlikely but very serious side effects occur:

A serious allergic reaction to Diazepam is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

precautions of Diazepam

Before using Diazepam, tell your doctor or pharmacist if we are allergic to it; or to other benzodiazepines ( e. g. , oxazepam, temazepam ) ; or if we have any other allergies.

Diazepam shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if we have:

Before using Diazepam, tell your doctor or pharmacist your medical history, especially of:

Diazepam may make we dizzy or drowsy; use caution while engaging in activities requiring alertness such as driving, riding a bicycle, or using machinery. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using Diazepam in elderly because they may be more sensitive to effects of Diazepam, especially drowsiness effect.

Diazepam isn't recommended for use during pregnancy. If you become pregnant or think we may be pregnant, inform your doctor immediately. Consult your doctor for more details.

Diazepam may pass into breast milk. Because of possible harm to the infant, breast-feeding while using Diazepam isn't recommended. Consult your doctor before breast-feeding.

interactions of Diazepam

Your healthcare professionals ( e. g. , doctor or pharmacist ) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change dosage of any medicine before checking with them first.

Diazepam shouldn't be used with following medications because a very serious interaction may occur while use Diazepam:

If you're currently using either of these medications, tell your doctor or pharmacist before using Diazepam.

Before using Diazepam, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of:

Tell your doctor or pharmacist if we also take drugs that cause drowsiness such as: antidepressants ( e. g. , amitriptyline, nefazodone ) , certain antihistamines ( e. g. , diphenhydramine ) , anti-seizure drugs ( e. g. , carbamazepine, phenobarbital, valproate ) , medicine for sleep or anxiety ( e. g. , alprazolam, kava, zolpidem ) , muscle relaxants, narcotic pain relievers ( e. g. , codeine ) , psychiatric medicines ( e. g. , chlorpromazine, risperidone ) .

Diazepam contains a small amount of alcohol. Tell your doctor if we are taking drugs such as disulfiram or metronidazole that can can cause an unpleasant reaction when combined with alcohol.

Avoid alcohol when using Diazepam because it may increase side effects such as difficulty breathing and drowsiness.

Check the labels on all your medicines ( e. g. , cough-and-cold products ) because they may contain drowsiness-causing ingredients. Ask your pharmacist about safe use of those products.

This document does not contain all possible interactions. Therefore, before using Diazepam, tell your doctor or pharmacist of all products you use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

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