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Cook Medical loses Houston-based IVC suit, plans to appeal
Cook Medical said today it lost a suit related to its Celect vena cava filters in Houston, but that it plans to appeal the decision.
The ruling came from a jury in Houston, which ruled in favor of a plaintiff, though the Bloomington, Ind.-based company did not release any detailed information related to the case.
“We are dedicated to providing life-saving treatment options for patients and will continue to defend all of our IVC filters. Our filters have saved thousands of lives, are clinically successful and are critical to patient well-being,” Cook Medical vascular division VP Mark Breedlove said in a prep...
Source: Mass Device - May 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Vascular Cook Medical Source Type: news
What the Netflix Documentary ‘Bleeding Edge’ Gets Right About the Dangers of Medical Devices in America
A new Netflix Original documentary sheds light on a topic that’s opaque to many: the medical device industry in America.
The film, called The Bleeding Edge, claims that the way medical devices make it to the U.S. market is lax and potentially dangerous. The filmmakers interview doctors and patients who say they’ve been personally harmed by an array of devices—including cobalt-based hip replacements, vaginal mesh and robotic surgery devices—and who feel that the guardian group of the medical device industry, the U.S. Food and Drug Administration (FDA), is not doing enough to protect them.
It’...
Source: TIME: Health - July 27, 2018 Category: Consumer Health News Authors: Alexandra Sifferlin Tags: Uncategorized Documentary Medical Devices medicine Netflix Netflix Original The Bleeding Edge Source Type: news
H & H Medical Introduces TACgauze Wound Wrapping Gauze: Innovative Product Brings Wound Gauze Manufacturing Back to US
WILLIAMSBURG, VA. -- For over fifty years, woven cotton gauze was standard protocol in controlling severe bleeding from wounds and for wound management. Packing wounds and wrapping injuries with cotton gauze is traditionally taught at all levels of military and civilian emergency medicine, however, domestic manufacturing of woven cotton gauze is proven to be expensive and most production has moved overseas.
Now, H&H Medical brings the production of cotton gauze for wound management back to the US. Based on a joint research program with the U.S. Department of Agriculture, TACgauze Wound Wrapping Gauze was developed to u...
Source: JEMS Patient Care - November 21, 2018 Category: Emergency Medicine Authors: H & H Medical (press release) Tags: Trauma Industry News Press Releases Source Type: news
Comparison of early clinical outcomes following transcatheter aortic valve implantation versus surgical aortic valve replacement versus optimal medical therapy in patients older than 80 years with symptomatic severe aortic stenosis.
CONCLUSION: Treatment with TAVI was associated with lower event rates compared to SAVR or OMT. Therefore, TAVI may be considered as the first therapeutic strategy in selected patients aged≥80 years with symptomatic severe AS.
PMID: 23549802 [PubMed - in process]
Source: Yonsei Medical Journal - May 1, 2013 Category: Universities & Medical Training Authors: Im E, Hong MK, Ko YG, Shin DH, Kim JS, Kim BK, Choi D, Shim CY, Chang HJ, Shim JK, Kwak YL, Lee S, Chang BC, Jang Y Tags: Yonsei Med J Source Type: research
Clinical Experience of Life-Threatening Dabigatran-Related Bleeding at a Large, Tertiary Care, Academic Medical Center: a Case Series.
CONCLUSION: Reversal strategies for dabigatran-related bleeding events at our institution are highly variable. Intracranial hemorrhage in patients on dabigatran was associated with 43 % mortality. Patients with severe dabigatran-related bleeding may benefit from a standardized approach to treatment.
PMID: 24385325 [PubMed - as supplied by publisher]
Source: Journal of Medical Toxicology - January 3, 2014 Category: Toxicology Authors: Ross B, Miller MA, Ditch K, Tran M Tags: J Med Toxicol Source Type: research
Accuracy of Transvaginal Ultrasonography for Detecting Intrauterine Lesions at a Taiwan Medical Center: A Correlation with Ultrasound and Hysteroscopic Histopathology
Conclusion TVUS had a sensitivity of 72.9% for diagnosing focal lesions. An ET ≥ 8 mm had a lower sensitivity for diagnosing benign intrauterine focal lesions. In our retrospective study group, AUB was not a good predictor for diagnosing focal intrauterine lesions even after treating ET as a fixed variance.
Source: Journal of Medical Ultrasound - October 13, 2014 Category: Radiology Source Type: research
Rural Trauma Patients Cannot Wait: Tranexamic Acid Administration by Helicopter Emergency Medical Services
Conclusion TXA must be administered before arrival at a trauma hospital to meet the recommendation of administration within 3 hours of injury for all patients transferred between facilities and for many patients transported from a trauma scene.
Source: Air Medical Journal - December 25, 2014 Category: Emergency Medicine Source Type: research
St. Teresa Medical launches Surgiclot system
St. Teresa Medical said yesterday it enrolled the 1st patient in a clinical trial of its Surgiclot clotting bandage.
The company won approval for a 40-patient study of Surgiclot from the U.K.’s Medicines and Healthcare products Regulatory Agency in June, St. Paul, Minn.-based St. Teresa said.
The 1st surgery using the bandage dressing was performed earlier this month by Sanjeev Madan at the Doncaster & Bassetlaw Hospital in South Yorkshire, U.K., the company said.
“It was Mr. Madan’s impression, as well as mine, that the reduction in blood loss was significant and dramatic, and that its use will lead...
Source: Mass Device - July 15, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials St Teresa Medical Source Type: news
Arsenal Medical wins $14m DoD contract
Arsenal Medical said today it won a contract from the U.S. Army Medical Research & Materiel Command worth more than $14 million to complete clinical and manufacturing development and regulatory submission for its ResQFoam.
Arsenal’s ResQFoam is a self-expanding biomaterial designed to be administered at the point of injury to stop blood loss in patients with severe internal bleeding in the abdomen due to life-threatening traumas. The material fills the wound and conforms to the abdominal cavity to control bleeding and can be removed before surgery, the company said.
“The strong governmental support we have ...
Source: Mass Device - December 9, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Wound Care Arsenal Medical Source Type: news
Medical management of an ovarian ectopic pregnancy: a case report
Conclusions
Ectopic ovarian pregnancy is a very important medical situation. It should be diagnosed in its early stages otherwise it could be life-threatening and surgical treatment may be inevitable. Because of the importance of fertility, medical treatment is an acceptable option and can be feasible with early diagnosis.
Source: Journal of Medical Case Reports - December 20, 2015 Category: Journals (General) Source Type: research
PerSys Medical partners with M.A.S. Med Global Ltd.
First Care Products Ltd. (a portfolio company of Persys Medical) announced the completion of a partnership agreement with M.A.S. Med Global Ltd., to develop and manufacture the ADAM Tourniquet, the first fully automated pneumatic tourniquet.
The ADAM Tourniquet combines state-of-the-art technology with pneumatics to create the first smart tourniquet. With a simple one-handed operation, it is applied, locked, and activated. A self-regulating valve controls the device’s pneumatic component, which inflates the tourniquet maintaining an optimal pressure for vascular occlusion. The ADAM Tourniquet communicates with hospital s...
Source: JEMS: Journal of Emergency Medical Services News - July 27, 2016 Category: Emergency Medicine Tags: Trauma Product Announcements Source Type: news
Dutch coating supplier ’ s recall gives Cook Medical another headache
A Dutch supplier’s recall led to another headache for Cook Medical, already scrambling to recover from a massive catheter recall, when it prompted a partial recall of a wire guide used during peripheral vascular interventions.
The Bloomington, Ind.-based medical device giant said the supplier for the hydrophilic coating used on its Roadrunner Uniglide wire guides, Holland’s DSM Biomedical, recalled some product on concerns that it had been contaminated with glass particles ranging in size from 4µm to 280µm.
Cook, which said it received 1 lot of the affected coating, pulled 8,750 of the Roadrunner UniGlid...
Source: Mass Device - August 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Recalls Regulatory/Compliance Cook Medical DSM Biomedical Source Type: news
Factors associated with significant MRI findings in medical walk-in patients with acute headache.
CONCLUSION: Among walk-in patients who underwent MRI for acute headache with low suspicion for intracranial bleeding, 20% had a significant MRI finding. A simple clinical score identified all patients with significant findings that explained the headache. If prospectively validated, this might be a useful tool in selecting those walk-in headache patients requiring urgent cranial MRI.
PMID: 28102882 [PubMed - in process]
Source: Swiss Medical Weekly - January 18, 2017 Category: Journals (General) Authors: Budweg J, Sprenger T, De Vere-Tyndall A, Hagenkord A, Stippich C, Berger CT Tags: Swiss Med Wkly Source Type: research
FDA green-lights Aegis Medical trial for Sierra ligation device
This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release.
“For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device,...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Aegis Medical Innovation Source Type: news
A randomized control trial to assess efficacy of Mifepristone in medical management of uterine fibroid
Conclusion Mifepristone when given in bi-weekly doses was found to be safe, efficacious, and cost effective as compared to treatment with tranexemic acid and mefenemic acid for management of fibroid uterus.
Source: Medical Journal Armed Forces India - April 11, 2017 Category: Journals (General) Source Type: research
