Anesthesia in Medical Technology

FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

... intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing ... persons trained in the administration of general anesthesia and that all patients should be continuously ... as it provides a new option for monitored anesthesia care (MAC) sedation in adult patients," said ...

Journal of the American Dental Association Publishes Key Clinical Data for the Use of OraVerse(TM) a Local Anesthetic Reversal Agent

... "Reversal of soft tissue local anesthesia with phentolamine mesylate in adolescents and ... OraVerse in reducing the duration of soft tissue anesthesia in patients receiving standard local anesthetic ... to accelerate the reversal of soft-tissue local anesthesia in children aged 6 to 11 years. No serious ...

BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union

... major pharmaceutical advance in the field of anesthesia in two decades. BRIDION is indicated for routine ... deep levels of muscle relaxation during general anesthesia was not possible before BRIDION," said Rajinder ... major pharmaceutical advance in the field of anesthesia in two decades. It was specifically designed to ...

FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent

... Committee Recommends FDA Approve Novel anesthesia Drug to Reverse Muscle ... has the potential to transform the practice of anesthesia through improved management of muscle relaxation ... Muscle relaxants are used as part of general anesthesia during surgical procedures. Sugammadex works ...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

... of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Eighty-nine (89) healthy ... been designed to meet the market demand for a low cost, fast onset local anesthesia product." Dharma has an end-of-phase 2 meeting scheduled with the ...

Two New Clinical Studies Show That Limited Exposure to Blood Transfusion Significantly Increases Morbidity and Mortality After Surgery

... conducted in patients undergoing cardiac surgery and published in the anesthesia & Analgesia - provide additional new evidence that transfusion of ... Cell Transfusions and Decreased Long-Term Survival After Cardiac Surgery. anesthesia & Analgesia 2009; 108:1741-1746. About Masimo Masimo ...

Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles

... ambulatory (outpatient) setting with no need for skin cooling products or anesthesia and took an average of 15 to 20 minutes, depending on size of the area. ... of the United States. Because this unique technology does not require anesthesia or cooling of the skin during the procedure, the physician can safely ...

Schering-Plough Announces European Launch of BRIDION(R) (Sugammadex)

... and represents the first major pharmaceutical advance in the field of anesthesia in two decades. BRIDION is indicated for routine reversal of the commonly ... years of age). Rocuronium and vecuronium are given as part of general anesthesia to relax a patient's muscles during surgery. BRIDION works in an ...

Urologist and Allergist Explore Link Between Allergies and Interstitial Cystitis

... decide which patients may benefit from allergy testing and treatment. Like many urologists, Hubbard uses cystoscopy and hydrodistention under anesthesia as part of his workup to exclude other conditions that may cause IC-like symptoms. But he is reviving an older practice of taking a biopsy specimen ...

New Studies Presented at European Society of Anaesthesia Further Validate Masimo PVI(TM) for Noninvasive and Continuous Fluid Monitoring

... and improvement of fluid status and preload" occurred "after administration of general anesthetic agents and intravenous fluid administration during anesthesia induction."(3) Michael O'Reilly, MD, EVP of Medical Affairs at Masimo, stated; "These studies confirm what previous results have shown--that ...

FDA Advisory Panel Recommends Approval of the SEDASYS(R) System

... to normal activities following a colonoscopy or EGD procedure. Current propofol labeling states only persons trained in the administration of general anesthesia should administer the drug. In the majority of practice settings, gastroenterologists do not have broad access to anesthesiologists. About ...

Melanoma and Pregnancy: What Every Woman Needs to Know About the Risks, Prognosis

... a wide local excision to remove the tumor. Dr. Driscoll explained that this procedure should not be delayed and can be safely performed under local anesthesia during pregnancy. In cases where a wide local excision must be performed in a later stage of pregnancy, the patient's obstetrician may be involved ...

Phase IV Multi-center Clinical Study of Kutai Concludes in Nanjing

... the Phase IV of the Kutai Multi-center clinical study project. Ms. Xinming Wu, Chief anesthetist of No.1 Hospital of Chinese Peking University anesthesia Department, presided over the conference and delivered a summary report of the Phase IV project. Xuejun Chen, Sinobiopharma's vice president of sales ...

Foreign Medical Devices are in High Demand in Russia

... surgical and medical instruments - Cardiovascular devices - ENT devices - Nephrology and urology devices - Neurology devices - anesthesia and respiratory devices - Endoscopy devices - Drug delivery devices - In vitro diagnostics - Diabetes care devices - Medical ...

Oridion Announces Significant Medical Studies Presented at STA

... 2 /PRNewswire-FirstCall/ -- Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN). During the recent annual meeting of the Society for Technology in anesthesia (STA) San Antonio, Texas, major new findings from numerous medical research projects demonstrating the clinical benefit of end-tidal CO2 (EtCO2) ...

Study Shows No Standardized Approach to Epidural Steroid Injections for Back Pain

... United States about their protocols regarding ESI. Results showed that no standard protocols with regard to type of steroid, dose or use of local anesthesia exist. In fact, the data showed that while most physicians use a moderate volume and dose of steroid, some physicians are giving very high volumes ...

Schering-Plough Highlights R&D Pipeline Progress, Innovation and Breadth of Research Projects

... receiving placebo; BRIDION(R) (sugammadex), the first and only selective relaxant binding agent for reversing neuromuscular blockade in anesthesia (approved in EU; under review in U.S. and Japan); Boceprevir, an oral protease inhibitor for treating hepatitis C with peginterferon and ...

Thermogard XP(TM) Studies to Be Presented at American Society of Anesthesiologists Annual Meeting

... room and the infusion of blood or other cold fluids. A patient's temperature can drop as much as 1 - 3 degrees F during the first 30 minutes after anesthesia is administered, and sometimes more body heat can be lost during the surgery, which can lead to serious complications including wound infections, ...

September 2008 Mayo Clinic Health Letter Highlights Cataract Removal, Severe Headache and Dual Energy X-Ray Imaging

... break up the clouded lens, which is suctioned out. Then, the surgeon inserts an artificial flexible lens. The outpatient procedure involves minimal anesthesia and tiny incisions. The standard lens implant has a single focus point (monofocal), meaning the implanted lens can't adjust for both distant and ...

U.S. FDA Issues Action Letter for Sugammadex

... vice president and president of Schering-Plough Research Institute. "Sugammadex represents the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work ...

ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia

... neuralgia pain management). Bupivacaine, the active agent in ELADUR, is a potent, FDA-approved long-acting local anesthetic used in regional anesthesia for local tissue infiltration, nerve block, and epidural and intrathecal anesthesia. DURECT currently retains full commercial rights to this product ...

Oridion Announces Major Medical Research and Congress Presentations

... and ROSC). The Symposium was moderated by Prof. Pierre Carli, President Societe Francaise d'Anesthesie et de Reanimation (French Society of anesthesia and Intensive Care). Two medical presentations given at European Society of Anesthesia demonstrated the importance of capnography for non-intubated ...

UltraShape(R) Non-Invasive Fat Reduction and Body Contouring Clinical Study Results Featured at American Society for Laser Medicine and Surgery Meeting

... The UltraShape procedure is performed during a convenient, "walk-in, walk-out" session carried out in an office-based environment; it requires no anesthesia or sedation, and the vast majority of patients report no pain or discomfort. After treatment, patients immediately resume their daily routines with ...

Independent Clinical Results Confirm Up to a 7-Centimeter Reduction in Body Circumference Using UltraShape(TM) Non-Invasive Fat Reduction and Body Contouring System

... The UltraShape procedure is performed during a convenient, "walk-in, walk-out" session carried out in an office-based environment; it requires no anesthesia or sedation, and the vast majority of patients report no pain or discomfort. After treatment, patients immediately resume their daily routines with ...

DURECT Announces Positive ELADUR(TM) Phase IIa Study Results

... neuralgia pain management). Bupivacaine, the active agent in ELADUR, is a potent, FDA-approved long-acting local anesthetic used in regional anesthesia including infiltration, nerve block, epidural and intrathecal anesthesia. About DURECT Corporation DURECT Corporation is an emerging specialty ...

Elekta Announces Clinical Start-Up of New Leksell Gamma Knife(R) Perfexion(TM) at UPMC

... outstanding results. Patients benefit from fast, painless treatment, often conducted in an outpatient surgical setting without the need for general anesthesia or even convalescence. To this date, about 500,000 patients have undergone Gamma Knife surgery. L. Dade Lunsford, M.D., F.A.C.S., is Lars Leksell ...

Sugammadex Trials Demonstrate Rapid Recovery from Profound Neuromuscular Blockade During General Anesthesia

... James E. Caldwell, University of California, San Francisco and one of the lead Signal trial investigators. Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents (NMBAs). Reversal of neuromuscular blockade enables spontaneous ...

Mayo Clinic Study Finds FDA Warning Against Anti-Nausea Drug Droperidol Unnecessary

... Minn., Sept. 28 /PRNewswire-USNewswire/ -- A Mayo Clinic review of patients' responses to a drug used to control nausea and vomiting during anesthesia for general surgery questions a U.S. Food and Drug Administration (FDA) warning against the drug's use. This study appears in the current issue of ...

DEFLUX(R) Significantly Reduces Urinary Tract Infections in Children With Vesicoureteral Reflux

... with parental assistance if required. DEFLUX, injected endoscopically where the ureter joins the bladder, is typically administered under general anesthesia as an outpatient procedure. The procedure is quick to perform (approximately 15 minutes) and no incision is required. The majority of VUR patients in ...

New Phase IV Clinical Study Indicates LidoSite Provides Rheumatology Patients Superior Pain Relief

... patients either received no local anesthesia or an alternate local anesthesia prior to cannulation or needle puncture. During the second treatment, ... may be considered medically necessary to administer local anesthesia prior to venipuncture or dermal procedures."(2) About the Clinical Study ...

Dharma Therapeutics Shows IDDS Is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in Their Phase 2 Clinical Trial

... a mild electric current, was safe and effective in delivering topical anesthesia in 8 minutes. About the trial: The trial was a Phase 2, ... of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Seventy one (71) healthy ...

MGI Pharma Announces Positive Results from a Pivotal Phase 3 Study of Aquavan Injection in Patients Undergoing Bronchoscopy

... of 2007. As is consistent with standard medical practice, the three trials comprising the Aquavan pivotal program were conducted without monitored anesthesia care (MAC) sedation, and study drugs were administered by medical personnel as dictated by local investigative site guidelines. "With more than ...

Landmark Findings From ECLIPSE Program Show Improved Control of Perioperative Hypertension Reduces Risk of Death In Cardiac Surgery

... a 150 percent increased risk of death. About Perioperative Hypertension Perioperative hypertension affects patients in the operating room, post- anesthesia care unit and intensive care unit. It is thought to be caused by the rapid shifts in blood volume and increased activity of the sympathetic nervous ...

Pivotal Phase III Findings With Investigational Drug Cleviprex (Clevidipine) Demonstrate Perioperative Blood Pressure Control In Cardiac Surgery

... compared to the other three agents. About Perioperative Hypertension Perioperative hypertension affects patients in the operating room, post- anesthesia care unit and intensive care unit. It is thought to be caused by the rapid shifts in blood volume and increased activity of the sympathetic nervous ...

The Lancet Publishes PREVAIL Study Results Showing Lovenox Superiority Over Unfractionated Heparin for Reducing the Risk of Venous ThromboEmbolism in Patients With Acute Ischemic Stroke

... they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins or heparinoids are at ...

Vical's Vaxfectin Adjuvant With Needle-free Delivery Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation Without Tolerability Issues

... electroporation following injection of unformulated vaccine yielded comparable improvements in antibody responses, but electroporation required anesthesia of the animals while needle-free injection of Vaxfectin(TM)-formulated vaccine was administered safely and tolerably without anesthesia. "The ...

International Movement Disorder Specialists Receive New Information About the Use of Once-Daily Azilect in the Treatment of Parkinson's Disease

... When taking AZILECT, you should not have elective surgery requiring general anesthesia, and should not receive cocaine or other local anesthesia that contains ingredients that could raise blood pressure. -- You should inform your physician if you are taking, or planning to take, ...

Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial Compared to Neostigmine

... Blobner from the Klinik für Anästhesiologie der Technischen Universität München, Germany. Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents (NMBAs). Reversal of neuromuscular blockade is used to reduce ...

Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial as Compared to Neostigmine

... Professor M. Blobner from the Klinik fur Anasthesiologie der Technischen Universitat Munchen, Germany. Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents (NMBAs). Reversal of neuromuscular blockade is used to reduce ...