Benefit May Not Outweigh Harm in AAA Screening Benefit May Not Outweigh Harm in AAA Screening
Swedish study finds screening for abdominal aortic aneurysm has no statistically significant effect on mortality, suggesting that other factors play a part in AAA incidence and death.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 27, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
Opioids and OD; Test for Diabetes: It's PodMed Double T! (with audio)
(MedPage Today) -- This week ' s topics include the emotional consequences of gun violence, a single test to diagnose diabetes, use of medicines to help addiction after opioid overdose, and screening for abdominal aortic aneurysm (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - June 23, 2018 Category: Psychiatry Source Type: news
FDA Issues Leak Safety Alert for Endologix AAA Repair Grafts FDA Issues Leak Safety Alert for Endologix AAA Repair Grafts
Regulators say the company ' s AFX endovascular graft system with Strata material -- used for abdominal aortic aneurysm repair -- is at greater risk for type III endoleaks compared with other devices for the same indication.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 19, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
Value of AAA screening drops as smoking declines
Mortality from abdominal aortic aneurysms (AAAs) has dropped sharply over the...Read more on AuntMinnie.comRelated Reading:
POCUS helps medical students find more AAAs than surgeons
USPSTF to take another look at AAA screening
Current AAA screening strategies may miss the mark
Vascular surgery society cautions use of US in AAA
USPSTF finalizes AAA screening recommendations (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - June 15, 2018 Category: Radiology Source Type: news
Cardinal Health deals majority stake in NaviHealth to PE shop CD & R
Cardinal Health (NYSE:CAH) said this week it divested itself of its majority stake in NaviHealth to private equity firm Clayton, Dubilier & Rice, with Cardinal Health retaining the call right to reacquire the business.
NaviHealth provides post-acute car programs to hospital systems, health planst, physician groups and healthcare providers as part of value-based care programs, Cardinal Health said.
Through the deal, CD&R will obtain a 55% ownership stake in NaviHealth, while Dublin, Ohio-based Cardinal Health will retain an approximate 45% stake in the post-acute care focused business.
“This new investment st...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Cardinal Health Source Type: news
Screen Does Not Cut Abdominal Aortic Aneurysm Mortality in Men
FRIDAY, June 15, 2018 -- Screening men for abdominal aortic aneurysm (AAA) does not reduce AAA-related mortality, according to a study published in the June 16 issue of The Lancet.
Minna Johansson, M.D., from the University of Gothenburg in Sweden,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 15, 2018 Category: Pharmaceuticals Source Type: news
FDA panel backs Cardinal Health ’ s Incraft stent graft
Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system.
The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced endovascular aneurysm system for treating infrarenal abdominal aortic aneurysms, the Dublin, Ohio-based company said.
The Incraft AAA system differs from other EVAR systems as it is intended to treat a wider range of patients, as many EVAR devices are limited ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Stent Grafts Vascular Cardinal Health Source Type: news
Cardinal Health ’ s Cordis wins date with FDA panel for Incraft AAA stent graft
Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms.
On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for the InCraft, which is currently under evaluation in the company’s Inspiration study.
The Inspiration study has already met its primary safety and effectiveness endpoints, but reported a higher than anticipated rate of certain adve...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Vascular Cardinal Health Cordis Corp. Source Type: news
MicroPort Scientific buys Lombard Medical out of bankruptcy
Lombard Medical Technologies (NSDQ:EVAR) said today that it was acquired out of bankruptcy by MicroPort Scientific (HK:00853), which hopes to get Lombard’s stent grafts on the market in China.
MicroPort put $15 million into Lombard back in December 2016 in a deal that aimed to accelerate the commercialization of Lombard’s Aorfix and Altura stent grafts for treating abdominal aortic aneurysms. Finalized in April 2017, the agreement called for MicroPort to make components for Aorfix and Altura at its facility in Shanghai and gave it exclusive marketing rights for Lombard products in China and Brazil.
Today Oxf...
Source: Mass Device - April 26, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Stent Grafts Wall Street Beat Lombard Medical MicroPort Scientific Source Type: news
Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients.
The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy.
“With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news
7 medtech stories we missed this week: March 23, 2018
[Image from unsplash.com]From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.
1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource
Medizone announced in a March 22 press release that it has signed a product evaluation agreement with Innovasource. As part of the agreement, Innovasource will be leading the evaluation of the AsepticSure system and compare it to existing cleaning practices in a number of facilities and settings. AsepticSure is designed ...
Source: Mass Device - March 23, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Food & Drug Administration (FDA) Hospital Care Imaging Implants Patient Monitoring Regulatory/Compliance Respiratory advantismedicalimaging aziyobiologics Balt endospan Medizone MedTech Olympus Respiratory Motion Source Type: news
After Many Missteps, Endologix Makes Progress on Nellix
Endologix just took a big step forward on what has been a long and winding road to FDA approval of its Nellix endovascular aneurysm sealing (EVAS) system. The Irvine, CA-based company said the first patient was treated in its EVAS2 confirmatory clinical study of the device.
The Nellix System was developed as an alternative treatment to traditional endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA). The system is designed to seal an entire aneurysm.
Endologix originally planned to have FDA approval of the Nellix system by the end of 2016, but the company hit a speed bump about midway through that yea...
Source: MDDI - March 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Regulatory and Compliance Source Type: news
Endologix launches study of second-gen Nellix endovascular aneurysm sealing system
Endologix (NSDQ:ELGX) said today that the first patient was treated in a study of its Nellix endovascular aneurysm sealing system.
The company’s Nellix system, designed to seal a patient’s entire aneurysm, is being developed as an alternative to traditional EVAR devices. Endologix’s system has CE Mark clearance in the European Union and is sold in a number of markets around the world.
The first patient in the company’s confirmatory IDE study was treated by Dr. Sajjad Hussain at St. Vincent Heart Center in Indiana. The EVAS2 trial is slated to enroll up to 90 patients and follow their progress over ...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Vascular Wall Street Beat Endologix Source Type: news
Study compares countries' mortality rates after aneurysm surgery
(Wiley) There is substantial international variation in mortality rates after treatment for abdominal aortic aneurysm, or enlargement of the aorta. A BJS (British Journal of Surgery) study that compared 10-year data from England and Sweden found that mortality rates were initially better in Sweden but improved over time alongside greater use of a minimally invasive procedure called endovascular aneurysm repair in England. Now there is no difference between postoperative mortality rates after aneurysm repair in England and Sweden. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 22, 2018 Category: International Medicine & Public Health Source Type: news
Medtronic launches Abre stent iliofemoral venous outflow obstruction IDE study
Medtronic (NYSE:MDT) said today it launched an FDA investigational device exemption study of its Abre venous self-expanding stent system, looking to explore the use of the device in subjects with iliofemoral venous outflow obstruction.
The first procedure in the study was performed last month by national principal investigator Dr. Erin Murphy of Charlotte, N.C.’s Sanger Heart & Vascular Institute, the Fridley, Minn.-based company said.
“The launch of the Abre IDE Study marks the beginning of an important journey to establish new options for the treatment of deep venous disease. The first procedure was per...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Medtronic Source Type: news
