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FDA: Cook Medical central venous cath recall is Class I
The FDA today labeled Cook Medical‘s recall of its central venous catheter and pressure monitoring sets and trays as Class I over issues with tip splitting and separation.
The devices being recalled are used to monitor pressure in a patient’s vein or artery, to sample blood and to administer drugs or fluids.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The devices are being recalled over issues with device tips splitting or separating from the catheters due to...
Source: Mass Device - March 30, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Recalls Cook Medical Source Type: news
Cook Medical recalls all 4m Beacon Tip catheters
The catheter recall that’s been bedeviling Cook Medical since last year grew last month as the company recalled all lots of catheters using its Beacon Tip locating technology.
The move stems from an increase in reports that the polymer used in the tips degrades over time, causing the tips to fracture or separate during procedures. Cook Medical said it’s received 30 reports of tip splitting to date.
The Bloomington, Ind.-based medical device giant recalled its 1st batch of Beacon Tip-equipped angiography catheters in August 2015, but the action quickly expanded to include other devices equipped with the loca...
Source: Mass Device - May 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Recalls Regulatory/Compliance Cook Medical Source Type: news
Cook Medical re-launches Beacon Tip caths in US, Canada
Cook Medical said today that it is re-launching its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.
The Bloomington, Ind.-based company recalled all catheters that used its Beacon Tip locating technology in May 2016 over complaints of tip splitting, affecting a total of approximately four million devices.
The company 1st noticed the problem in early 2015, initially recalling only the smallest size Beacon Tip angiography catheter.
Cook Medical said its engineering team completed significant testi...
Source: Mass Device - April 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Cook Medical Source Type: news
Inari Medical touts FlowTriever pulmonary embolism study data
Inari Medical today presented results from a study of its FlowTriever retrieval and aspiration system designed to treat pulmonary embolism, touting the safety and efficacy of the system.
Results were presented by Dr. Thomas Tu of Louisville, Ky.’s Baptist Health at the Scientific Sessions of the Society for Cardiovascular Angiography and Interventions in San Diego, Irvine, Calif.-based Inari Medical said.
“The significant improvement in right heart function shown with the FlowTriever system compares very favorably with outcomes of other techniques used to treat PE. At the same time, the impressive safety profil...
Source: Mass Device - April 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Inari Medical Source Type: news
Coronary computed tomography angiography versus invasive coronary angiography: medical staff perceptions and diagnostic interest in Gaza-Palestine
ConclusionEfficient diagnostic benefits of CCTA and overuse of ICA for stable CAD are documented. Clear diagnostic strategy with medical, ethical, and logistical issues should be considered when selecting the CCTA or ICA for diagnosis CAD.
Source: Irish Journal of Medical Science - September 24, 2020 Category: General Medicine Source Type: research
St. Jude Medical launches OCT stenting trial
St. Jude Medical (NYSE:STJ) today said it’s launching the 1st trial comparing optical coherence tomography device with intravascular ultrasound or angiography during stenting procedures.
St. Paul, Minn.-based St. Jude said the 420-patient Ilumien III trial will compare treatment with its Optis Integrated and Ilumien Optis percutaneous coronary intervention optimization systems in treating patients with stable or unstable angina, silent ischemia or NSTEMI or STEMI heart attacks. Subjects will be randomized to undergo PCI with either OCT, angiography or IVUS, with a primary endpoint of the degree of minimum ste...
Source: Mass Device - June 30, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Imaging St. Jude Medical Source Type: news
Kips Bay Medical shareholders OK shutdown
Kips Bay Medical (OTC:KIPS) shareholders today approved the company’s dissolution, after the Minneapolis-based medical device company’s feasibility trial failed.
Kips Bay said in June that it would pull the plug after terminating the Emesh I clinical feasibility trial of its eSVS mesh based on poor 6-month results.
Today the company said founder, chairman & CEO Manny Villafaña, the medtech legend behind STJ, has resigned from Kips Bay, which he named after a boyhood club he credits with setting him on his life’s path.
Kips Bay named COO/CFO Scott Kellen to replace Villafaña until the shutdown i...
Source: Mass Device - September 22, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Wall Street Beat Kips Bay Medical Inc. Source Type: news
St. Jude Medical launches Optis Mobile in Europe, Japan
St. Jude Medical (NYSE:STJ) said today that it’s launching its Optis Mobile OCT-FFR lab in Europe and Japan.
Little Canada, Minn.-based St. Jude said the portable Optis Mobile is designed for hospitals with multiple cardiac catheterization labs and combines optical coherence tomography and angiography co-registration with fractional flow reserve.
“The Optis Mobile system represents the ongoing commitment of St. Jude Medical to develop products that provide physicians with more options for improved OCT and angiography co-registration guidance in their daily practice,” group president Dr. Eric Fain sa...
Source: Mass Device - February 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Imaging Stents St. Jude Medical Source Type: news
UPDATE: Cook Medical recalls all 4m Beacon Tip catheters
UPDATED May 5, 2016, with comment from Cook Group president Pete Yonkman.
The catheter recall that’s been bedeviling Cook Medical since last year grew last month as the company recalled all lots of catheters using its Beacon Tip locating technology, but the company expects to have replacement catheters on the market within the next several weeks.
The move stems from an increase in reports that the polymer used in the tips degrades over time, causing the tips to fracture or separate during procedures. Cook Medical said it’s received 30 reports of tip splitting to date, prompting the recall of some 4 million ...
Source: Mass Device - May 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Recalls Regulatory/Compliance Cook Medical Source Type: news
Osprey Medical raises $21.3m
Osprey Medical (ASX:OSP) said it raised $21.3 million (AUD $28 million) through the sale of CHESS depository interests to support the expanded commercialization of its DyVert System and ongoing research and development.
The Australian company raised the funds from institutional investors through the sale of 100 million CDIs at 21¢ (AUD 28¢) per CDI, set to take place in 2 tranches.
The 1st tranche consists of 38.5 million CDIs, representing 19.3 million shares of common stock, followed by a 2nd tranche of 61.5 million CDIs, worth approximately 30.8 million common shares.
“We are delighted with the oversubscribed pl...
Source: Mass Device - August 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Imaging Osprey Medical 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
TriReme Medical touts Chocolate Heart drug-coated balloon data
QT Vascular subsidiary TriReme Medical touted angiographic data today from a 24-month follow-up of patients treated with its Chocolate Heart drug-coated balloon.
The Chocolate Heart device is a paclitaxel-coated version of the company’s Chocolate coronary balloon that is commercially available in the U.S. The combo therapy was designed to reduce the incidence of repeat procedures and minimize the need for a stent, according to TriReme.
Get the full story at our sister site, Drug Delivery Business News.
The post TriReme Medical touts Chocolate Heart drug-coated balloon data appeared first on MassDevice.
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Pharmaceuticals QT Vascular TriReme Medical Inc. Source Type: news
ConvNet-Based Localization of Anatomical Structures in 3-D Medical Images
Localization of anatomical structures is a prerequisite for many tasks in a medical image analysis. We propose a method for automatic localization of one or more anatomical structures in 3-D medical images through detection of their presence in 2-D image slices using a convolutional neural network (ConvNet). A single ConvNet is trained to detect the presence of the anatomical structure of interest in axial, coronal, and sagittal slices extracted from a 3-D image. To allow the ConvNet to analyze slices of different sizes, spatial pyramid pooling is applied. After detection, 3-D bounding boxes are created by combining the ou...
Source: IEE Transactions on Medical Imaging - July 1, 2017 Category: Biomedical Engineering Source Type: research
Embolization of arterial gastrointestinal hemorrhage with Fuaile medical adhesive
Conclusion FAL embolotherapy has a high success rate for arterial GIH that was unresponsive to internal medicine treatment and gastroscopy management, with low postoperative rates of bleeding and complications; thus, this method has a high cost-efficacy.
Source: Journal of the Chinese Medical Association - December 2, 2017 Category: General Medicine Source Type: research
Five-Year Outcomes of Successful Percutaneous Coronary Intervention with Drug-Eluting Stents versus Medical Therapy for Chronic Total Occlusions.
CONCLUSION: In this study, successful CTO PCI with DESs was associated with a higher risk of repeat PCI for the target vessel, but showed a reduced incidence of death or MI.
PMID: 29869458 [PubMed - in process]
Source: Yonsei Medical Journal - June 6, 2018 Category: Universities & Medical Training Authors: Rha SW, Choi BG, Baek MJ, Ryu YG, Li H, Choi SY, Byun JK, Mashaly A, Park Y, Jang WY, Kim W, Choi JY, Park EJ, Na JO, Choi CU, Lim HE, Kim EJ, Park CG, Seo HS, Oh DJ Tags: Yonsei Med J Source Type: research
