Medtronic touts Endurant AAA graft 4-year data
Medtronic (NYSE:MDT) said today that 4-year real world data from a subset of patients with challenging anatomy implanted with the Endurant AAA stent graft system showed durable outcomes. The data was presented at the VEITHsymposium in New York City.
At 4-years, no differences in IA endoleak rate or AAA diameter increases were found between subsets of patients with short necks and standard necks, the company said, and freedom from aneurysm-related mortality was 99.2% for the short neck cohort and 98.3% for standard length neck patients.
“Analysis of the patient cohort from the 4-year global Engage registry included ...
Source: Mass Device - November 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Stent Grafts Vascular Medtronic Source Type: news
Medtech approvals: FDA releases September 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015:
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 53
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 31
Total On Hold: 24
Summary of PMA Supplements Under Review
Total Under Review: 611
Total Active: 461
Total On Hold: 150
Summary of All PMA Submissions
Originals: 3
Supplements: 84
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 127.6
FDA Time: ...
Source: Mass Device - November 16, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
FDA clears Endologix’ AFX2 bifurcated stent graft
Endologix (NSDQ:ELGX) said it won FDA premarket approval for its AFX2 bifurcated endograft system for treating abdominal aortic aneurysms.
The system is the newest-generation of AFX endovascular AAA product from the Irvine, Calif.-based company. The new version of the device reduces delivery and deployment procedure steps and can facilitate percutaneous endovascular aneurysm repair through a low-profile 7F introducer.
“The AFX system is already uniquely positioned as the only anatomical fixation EVAR device on the market. With the approval of AFX2, we have taken a versatile platform and combined it with an easy to ...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Stent Grafts Stents Endologix Inc. Source Type: news
Bolton Medical wins CE Mark for Treo stent graft
Bolton Medical said today it won CE Mark approval in the European Union for its Treo abdominal stent-graft for treating abdominal aortic aneurysms.
The endovascular aneurysm repair device is designed as a modular 3-piece system with dual proximal fixation and a unique proximal clasping mechanism, the Sunrise, Fla.-based company said.
“We believe that in EVAR, the tri-modular strategy is the best approach. This is because it allows you to deliver a tailored solution to each patient by selecting specific components to precisely work in that individual anatomy,” R&D veep Scott Rush said in prepared remarks.
T...
Source: Mass Device - September 24, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Bolton Medical Source Type: news
Lombard Medical Names David Milne to Board of Directors
IRVINE, Calif., Sept. 8, 2015 -- (Healthcare Sales & Marketing Network) -- Lombard Medical Inc. (EVAR), a medical device company focused on endovascular aortic repair of abdominal aortic aneurysms, today announced that medical device executive and investor... Devices, Interventional, PersonnelLombard Medical, Aorfix, abdominal aortic aneurysm, AAA (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 8, 2015 Category: Pharmaceuticals Source Type: news
Endovascular Aortic Aneurysm Repair May Have Trade-offsEndovascular Aortic Aneurysm Repair May Have Trade-offs
Compared with open repair, mortality rates were lower for patients with endovascular repair through the third year of follow-up, when the pattern shifted. Medscape Medical News (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 4, 2015 Category: Surgery Tags: General Surgery News Source Type: news
Long-Term Survival Better with Less Invasive AAA Repair (CME/CE)
(MedPage Today) -- Survival with endovascular repair superior to open surgery (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 3, 2015 Category: Cardiology Source Type: news
MassDevice.com +3 | The top 3 medtech stories for August 24, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. ‘Go-shop’ lapses without new rival for St. Jude’s $3B Thoratec buy
A 30-day “go-shop” period in St. Jude Medical’s pending, $3.4 billion acquisition of Thoratec lapsed without a 2nd suitor emerging, sending the companies’ stock prices down slightly.
Th...
Source: Mass Device - August 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
TriVascular Technologies raises $10m, launches study of EVAR in women
Trivascular Technologies (NSDQ:TRIV) said it raised a $10 million funding round and launched a clinical study of endovascular aortic repair in women using its Ovation stent graft.
Santa Rosa, Calif.-based TriVascular said in a regulatory filing that it raised $10 million from 5 unnamed investors in a debt-and-warrants offering. The company, which won pre-market approval from the FDA this month for its Ovation iX device, raised $78 million in April 2014 with an initial public offering.
TriVascular also said today that it launched the Lucy study, which aims to enroll up to 225 subjects (75 women in the treatment cohort a...
Source: Mass Device - August 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Endoscopic / Arthroscopic Stent Grafts Vascular TriVascular Source Type: news
GPOs: Nihon Kohden inks deal with Novation
Nihon Kohden (TYO:6849) said Tuesday they signed a 3-year group purchase order agreement with healthcare service company Novation.
The deal positions Japan-based Nihon Kohden to provide Novation with sleep assessment and neurodiagnostic services and equipment. The contract became effective July 1st, according to the companies.
“We are honored to be a partner with Novation, as our 2 organizations share a commitment to leading healthcare innovation that increases quality across the continuum. The organization’s deep customer base will enable us to further our goal of providing integrated solutions that work across ...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics Neurological Nihon Kohden Novation Source Type: news
Altura Medical sold to Lombard Medical for up to $50.5M
Altura Medical, a venture-backed stent graft developer, has been acquired by Lombard Medical in a deal valued at up to $50.5 million.
Irvine-based Lombard is issuing $15 million of its stock (NASDAQ:EVAR) at $4 a share in connection to the deal, taking on $5.5 million in bank debt and assuming $2.5 million in certain liabilities and transaction-related costs.
Get the free daily TechFlash Silicon Valley newsletter.
It has also agreed to $27.5 million more in payments tied to milestones being… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 30, 2015 Category: American Health Authors: Cromwell Schubarth Source Type: news
Lombard purchases endograft developer Altura
Lombard Medical Technologies (NSDQ:EVAR) said today it acquired endovascular stent graft developer Altura Medical.
Altura develops ultra-low profile endovascular stent graft technology intended for the treatment of abdominal aortic aneurysms, in line with Lombard’s own technologies and their flagship Aorfix endograft.
The terms of the transaction between Irvine, Calif.-based Lombard and Silicon Valley-based Altura medical included the issuance of $15 million of Lombard stock at $4 per share, the assumption of $5.5 million in debt and $2.5 million in liabilities and transaction related costs, Lombard said.
“Th...
Source: Mass Device - July 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Stent Grafts Altura Medical Devices Lombard Medical Technologies Source Type: news
Lombard Medical looks to M&A to grow beyond AorFix
Lombard Medical Technologies (NSDQ:EVAR) CEO Simon Hubbert this week said the stent graft maker is looking beyond the abdominal aortic aneurysm repair market, aiming to grow out of being a 1-product company either via acquisition or a distribution deal with a larger medical device company.
Discussing Lombard’s 2nd-quarter results July 27, Hubbert referenced the $110 million buyout of Aptus Endosystems by Medtronic (NYSE:MDT) last month, observing that the crowded and competitive abdominal aortic aneurysm repair market is driving consolidation.
“We believe this environment presents us with the opportunit...
Source: Mass Device - July 29, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: MassDevice Earnings Roundup Mergers & Acquisitions Stent Grafts Lombard Medical Source Type: news
Abdominal Aneurysms: Early Benefits for Endovascular RepairAbdominal Aneurysms: Early Benefits for Endovascular Repair
Patients had less perioperative mortality with endovascular repair than open repair, but higher risk for rupture years after surgery. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 23, 2015 Category: Consumer Health News Tags: General Surgery News Source Type: news
Endovascular and Open Repairs of Abdominal Aortic Aneurysms Have Similar Long-Term Mortality Rates
By Christine Sadlowski
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
After endovascular repair of abdominal aortic aneurysms, mortality rises over time but doesn't surpass that associated with open repair, a … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - July 23, 2015 Category: Primary Care Source Type: news
