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Is There Hope for an Endologix Comeback?
A year ago, Endologix CEO John McDermott walked into the VEITHsymposium at the New York Hilton-Midtown, saw the look on the face of his head of regulatory and clinical affairs as he approached the Endologix booth, and knew something was wrong. Sure enough, FDA had just asked Endologix to provide two-year patient follow-up data from its EVAS-FORWARD study of the Nellix endovascular aneurysm sealing (EVAS) system. "So that night we worked through the night to get out our press release first thing the next morning to inform the world that there was going to be pushback in the timeline and the clinical requirements,&...
Source: MDDI - November 19, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Cath Lab Recap: TAVR & Femoral Artery Integrity; DNA Damage During EVAR
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 27, 2017 Category: Cardiology Source Type: news

This Device Has Been Around for 20 Years
It comes in different sizes and configurations now, but the Gore Excluder AAA Endoprosthesis, which seals off abdominal aneurysms from inside the aorta, hasn’t changed radically since it was introduced to the European market in 1997. The endovascular aneurysm repair (EVAR) device has been implanted in more than 300,000 patients diagnosed with an abdominal aortic aneurysm (AAA), according to its manufacturer, W.L. Gore & Associates. Before EVAR, patients with AAA had two options: major surgery to repair the aneurysm or crossed fingers. “The number of patients who were not candidates for surgery really drove ...
Source: MDDI - October 13, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Implants Design Source Type: news

Lombard touts expected 50% cost reduction in restructuring effort
Lombard Medical Technologies (NSDQ:EVAR) said today it completed a restructuring of its business after implementing a plan to focus its sales efforts on the UK, Japan and China, as well as reducing operating and manufacturing costs as it seeks to breakeven with its cash flow. The UK-based company said that the restructuring is expected to result in a reudction of nearly $12 million in operating expenses next year when compared to last years expenditure levels, with costs reduced more than 50%. “During 2017, we have refocused sales and marketing activities in an effort to concentrate on our highest margin markets...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News lombardmedical MicroPort Scientific Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 14, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters.   5. How Boston Scientific is boosting medical device value Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data
Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair. The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease. Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials Distribution Research & Development Stents Vascular Endologix Source Type: news

Medtronic touts 5-year gendered sub-analysis data from Endurant AAA stent graft trial
Medtronic (NYSE:MDT) today released new 5-year data from a gender separated subset of the Engage trial of its Endurant II abdominal aortic aneurysm stent graft system. The subset analysis aimed to compare results across both male and female patients. Fridley, Minn.-based Medtronic said that historically, women have had worse EVAR outcomes than men due to anatomy differences, including more angulated aortic necks and smaller aneurysms and iliac vessels. The analysis included 1,263 patients, with 133 female and 1,130 males. For women in the study, data indicated a 99.2% rate of successful delivery and eployment, only 0....
Source: Mass Device - September 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Medtronic Source Type: news

Cath Lab Recap: High-Speed OCT; EVAR; Restenosis Revasc Rising
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 1, 2017 Category: Cardiology Source Type: news

Nonoperative management rather than endovascular repair may be safe for grade II blunt traumatic aortic injuries: an eleven year retrospective analysis - Spencer SM, Safcsak K, Smith CP, Cheatham ML, Bhullar IS.
BACKGROUND: The Society of Vascular Surgery (SVS) guidelines currently suggest thoracic endovascular aortic repair (TEVAR) for grade II-IV and non-operative management (NOM) for grade I blunt traumatic aortic injury (BTAI). However, there is increasing evi... (Source: SafetyLit)
Source: SafetyLit - June 28, 2017 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Endologix touts 30-day data from study of Ovation stent graft in women
Endologix (NSDQ:ELGX) touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women. The Lucy trial showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair when using the Ovation stent graft. The study is the 1st to assess endovascular aneurysm repair outcomes in women, according to Endologix. Previous research has shown that aneurysms grow faster in women compared to men and that female anatomy is more challenging for most traditional treatment methods. The company’s 225-patient trial included 76 females in the treatment group ...
Source: Mass Device - June 1, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Vascular Women's Health Endologix Source Type: news

Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region. The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. “Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR. In many patients, it is imperative that iliac artery ...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular W.L. Gore & Associates Source Type: news

7 medtech stories we missed this week: May 19, 2017
[Image from unsplash.com]From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of th...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Body Vision Medical Exactech Inc. Lombard Medical Technologies MedTech NxThera Inc. Rivanna Medical Visionsense XpandOrtho Source Type: news

Lombard Medical CEO Hubbert, CFO Kullback step down | Personnel Moves, April 28, 2017
Lombard Medical Technologies (NSDQ:EVAR) said this month that its CEO Simon Hubbert and CFO William Kullback are stepping down from their positions, with Kurt Lemvigh stepping into the CEO role. Hubbert served as CEO for 6 years after joining the company in 2010, and will be replaced by Lemvigh, who has held positions with multiple companies, including Cardiac Science and GE (NYSE:GE). “Lombard represents a unique opportunity given the strength of the company’s portfolio in the over $1.5 billion market for endovascular repair products. The key to success will be our ability to leverage the work t...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Accuray Inc. Becton Dickinson & Co. Boston Scientific Cardiac Sciences Corp. ConMed Corp. Fresenius GE Healthcare Lombard Medical Technologies Magnolia Medical Technologies ReWalk Robotics Senseonics Toshiba Source Type: news

Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device. Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 Charing Cross Symposium in London this week. “Medtronic aims to increase access to treatment for patients with aortic disease. This goal has been reinforced by our commitment to developing robust clinical programs – such as the Engage registry &ndas...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Endoscopic / Arthroscopic Stent Grafts Vascular Medtronic Source Type: news

Benefits of Endovascular Treatment for Stroke Last at Least 2 Years (FREE)
By Kelly Young Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM The functional benefits of endovascular repair after acute stroke appear to be sustained after 2 years, according to a follow-up … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - April 5, 2017 Category: Primary Care Source Type: news

Endologix inks $170m credit facility with Deerfield
Endologix (NSDQ:ELGX) said this week it inked a credit facility worth up to $170 million with Deerfield Management. Money in the facility will be provided through a $120 million 6-year secured term loan and a $50 million 3-year secured asset-based revolving line of credit, the Irvine, Calif.-based company said. Under the loan facility, Deerfield will provide Endologix with $120 million or gross proceeds in funding, with Endologix agreeing to pay Deerfield a yield enhancement payment equal to 2.25% of the principal amount at the time of funding. Endologix can, at its option, repay the loan at any time. The company said...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Endologix Source Type: news

Trumpcare ’ s prospects dim, but not too dim to hit stent graft makers
The push on Capitol Hill to revive Trumpcare stalled yesterday, but not before the chatter out of Washington instigated a slide for stent graft makers’ stocks. The Affordable Care Act covers a 1-time screening for abdominal aortic aneurysms in men who smoke or smoked in the past, listing the test as an “essential health benefit.” The GOP’s healthcare reform proposal would do away with the AAA screening coverage, shifting the cost of the test to patients, which could in turn affect AAA repair procedure volumes. Investors reacted by pushing share prices down yesterday on Wall Street for Lombard M...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Healthcare Reform Stent Grafts Wall Street Beat C.R. Bard Capitol Hill Endologix Lombard Medical Technologies Source Type: news

Lombard, MicroPort finalize strategic partnership
Lombard Medical Technologies (NSDQ:EVAR) said today it finalized a strategic partnership deal with MicroPort Scientific. Through the partnership, MicroPort will manufacture certain components for Lombard’s Aorfix and Altura product lines at its Shanghai facilities, slated to begin in the 2nd half of this year. “This strategic partnership begins to establish the foundation for improved gross margins for Lombard by significantly reducing the manufacturing costs of both Aorfix and Altura devices which, in turn, will allow Lombard to be competitive in all of our markets. Moreover, given MicroPort’s excep...
Source: Mass Device - April 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular Lombard Medical Technologies MicroPort Scientific Source Type: news

MicroPort, undaunted by price caps, enters India ’ s stent market
MicroPort has entered the Indian market only days after the country’s National Pharmaceutical Pricing Authority imposed a price cap on coronary stents. The Shanghai-based company said its Firehawk Rapamycin target eluting coronary stent system was successfully used in a procedure in Mumbai earlier in the month, marking the 1st time the device saw use in the country. The procedure was performed at H. J. Doshi Ghatkopar Hindu Sabha Hospital in Mumbai, by Dr. Anil Potdar, according to a press release. The company touted the Indian market as having the 3rd largest amount of PCI cases in the world, and promised future exp...
Source: Mass Device - February 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Stents MicroPort Scientific Source Type: news

Cath Lab Recap: Fully Percutaneous EVAR; Aneurysms Within BVS
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 9, 2017 Category: Cardiology Source Type: news

Lombard wins Japanese clearance for IntelliFlex LP delivery device for Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its Intelliflex low profile delivery system for the Aorfix endovascular stent graft. The Oxfordshire, England-based company said it will initiate a commercial launch of the device in Japan once it receives reimbursement approval, expected some time next month. Currently, Medico’s Hirata has exclusive distribution rights to the Aorfix. “We have enjoyed great success already with Aorfix in Japan and built our market share to approximately 8% over the last two years. Now with t...
Source: Mass Device - January 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Lombard Medical Technologies Source Type: news

China ’ s Microport puts $15m into Lombard Medical
Lombard Medical Technologies (NSDQ:EVAR) said today that China’s MicroPort Orthopedics invested $15 million as part of a partnership deal between the 2 companies. Through the partnership, Lombard will seek to accelerate commercialization of its Arofix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as well as a license to manufacture the products for the Chinese market. As part of the deal, Microport and Lombard said they entered a component supply manufacturing deal, with Microport manufacturing comp...
Source: Mass Device - December 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Mergers & Acquisitions Stent Grafts Vascular Lombard Medical Technologies MicroPort Scientific Source Type: news

Essential Medical Inc. Announces the Successful Initiation of the U.S. MANTA Vascular Closure Device Trial With the First Patients Enrolled in TAVR and EVAR Cases
MALVERN, Pennsylvania, December 12, 2016 -- (Healthcare Sales & Marketing Network) -- Essential Medical, Inc., a privately held medical device company addressing the rapidly growing $600M large bore vascular closure market, announced today the start of th... Devices, Interventional, Cardiology Essential Medical, MANTA, Vascular Closure, TAVR (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 12, 2016 Category: Pharmaceuticals Source Type: news

Medtronic wins expanded CE Mark indication for Endurant II stent graft
Medtronic (NYSE:MDT) said today that it won an expanded CE Mark indication in the European Union for its Endurant II/IIs stent graft for treating abdominal aortic aneurysms. The expanded indication covers a new endovascular implantation approach using a parallel graft chimney approach called ChEVAR, which allows the device to be used to treat aneurysms with an aortic neck length of 2mm or more. Aortic neck length is the distance from the renal arteries to the aneurysm. The ChEVAR approach, which uses balloon-expandable covered stents in the renal arteries and a stent graft in the aorta, is designed to increase the infraren...
Source: Mass Device - December 6, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Regulatory/Compliance Stent Grafts Medtronic Source Type: news

Veith 2016 Roundup: Stent grafts take center stage
Medtronic touts Endurant stent graft data from Engage study Medtronic (NYSE:MDT) touted data from a series of sub-group analyses from the 10-year 1,200-patient Engage study of its Endurant II and Endurant IIs stent grafts for treating abdominal aortic aneurysms last week at the annual Veith Symposium on vascular disease. First-time results from a review of the occurrence of endoleaks at the aneurysm neck, presented by Dr. Hence Verhagen of Erasmus University Medical Center in Rotterdam, Holland, showed a 97.8% rate of freedom from Type Ia endoleaks at 1 year. The rate was 97.3% at 2, 96.7% at 3 years and 96%...
Source: Mass Device - November 21, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Stent Grafts Stents Vascular Biotronik Endologix Inc. Medtronic Veith Symposium 2016 W.L. Gore & Associates Source Type: news

Endovascular Repair May Be Effective for Ascending Aortic Dissection Endovascular Repair May Be Effective for Ascending Aortic Dissection
Endovascular repair appears to be effective for ascending aortic dissection in patients ineligible for open repair, researchers from China report.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - November 1, 2016 Category: Radiology Tags: News Source Type: news

Follow-Up Essential After Endovascular AAA Repair Follow-Up Essential After Endovascular AAA Repair
Compared to an open approach, endovascular repair (EVAR) of abdominal aortic aneurysm (AAA) offers early survival benefit but shows inferior late survival, according to UK researchers.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - October 31, 2016 Category: Radiology Tags: Neurology & Neurosurgery News Source Type: news

Gore wins Medicare add-on status for Excluder stent graft
W.L. Gore & Assoc. said today that it won new technology status from the U.S. Centers for Medicare & Medicaid Services for its Gore Excluder iliac branch endoprosthesis. Set to go into effect Oct. 1, the change will allow facilities that use the device, in conjunction with Gore’s Excluder AAA device for endovascular aneurysm repair, to be eligible for a new tech add-on payment of up to $5,250 per case. The payment will come in addition to the applicable base payment for the Medicare Severity Diagnosis-related group. “Prior to the IBE, there were limited options for maintaining blood flow ...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Stent Grafts Vascular Reimbursement W.L. Gore & Associates Source Type: news

Gore launches DrySeal Flex introducer sheath
W.L. Gore & Associates said today it is launching its DrySeal Flex introducer sheath designed for use with its Gore Excluder iliac branch endoprosthesis device, which is used for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The newly-launched device is designed with improved flexibility, kink resistance and a hydrophilic coating to allow for access in challenging anatomies and branch vessels during endovascular repair procedures. “Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery. The IBE is a trusted solution in such cas...
Source: Mass Device - August 30, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Vascular W.L. Gore & Associates Source Type: news

Endologix touts 1st Ovation Alto stent graft implantations
Endologix (NSDQ:ELGX) last week announced that its Ovation Alto abdominal stent graft system has been used in its 1st 2 procedures to treat abdominal aortic anneurysms. The procedures were performed at New Zealand’s Auckland City Hospital by Dr. Andrew Holden and Dr. Andrew Hill, the Irvine, Calif.-based company said. “The 1st patients treated with the Ovation Alto system is a significant milestone for our new product strategy. It further enhances our leadership position in the development of unique sealing technologies for the treatment of AAA and broadens our product portfolio to address a...
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Surgical Vascular Endologix Inc. Source Type: news

Lombard Medical exits U.S. market, shares jump
Lombard Medical Technologies (NSDQ:EVAR) said yesterday that it’s bailing out of the U.S. market after an FDA decision requiring a 50-patient clinical study of its Intelliflex low-profile delivery system for the Aorfix stent graft. Lombard said it eliminated its U.S. sales force and moved most of its commercial operations to its U.K. facility, significantly reducing its cash burn. Irvine, Calif.-based Lombard said it plans to focus exclusively on the European Union, Japan and other “key” international markets. The company in June won CE Mark approval in the European Union for the ...
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Endoscopic / Arthroscopic MassDevice Earnings Roundup Stent Grafts Wall Street Beat Lombard Medical Technologies Source Type: news

InSeal Medical wins CE Mark for vascular closure device
InSeal Medical said today it won CE Mark approval in the European Union for its InClosure vascular closure device designed to close large bore arterial punctures. The device is implanted percutaneously and requires no pre-procedure or sheath exchange and features a biodegradable membrane which is coupled to the vessel wall by a thin Nitinol frame, the Israel-based company said. “The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR. Based on our growing experience, the InClosure VCD allows for a smoother and safer TAVR procedure without pre...
Source: Mass Device - August 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance InSeal Medical Ltd. Source Type: news

Endologix releases Q2, updates on Nellix discussions with FDA
Endologix (NSDQ:ELGX) on Wednesday released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is requesting additional information and may need an Advisory Committee Panel before it can obtain approval. The company said that without a required panel, it is hopeful it will receive premarket approval from the FDA for the device in the 1st quarter of 2017. With a required panel, the company expects approval some time in the 3rd quarter of 2017. “In July, we completed our 100-day PMA meeting with the FDA and remain confi...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Vascular Endologix Inc. Source Type: news

Medtronic touts 5-year Endurant stent graft data
More than 5 years after Medtronic‘s (NYSE:MDT) Endurant Stent Graft System 1st gained FDA approval, the medical device giant has released data pointing to long-term durability of the treatment for abdominal aortic aneurisms. Healio reported that Endurant showed durability and safety in patients 5 years after treatment, according to details published in the Journal of Vascular Surgery. What they found: mortality rates were about 17.7%, and the rates of non-aneurysm-related mortality surpassed 99 percent, Healio noted. Only 1 patient in the assessment suffered from an aneurysm- death after declining trea...
Source: Mass Device - July 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Stent Grafts Stents Medtronic Source Type: news

FDA approves trial for Essential Medical’s Manta vascular closure device
Essential Medical said today that it won an investigational device exemption for a clinical trial of its Manta vascular closure device. The Manta device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website. The U.S. pivotal study is designed to assess the safety and efficacy of the Manta device in closing access sites on the femoral artery for percutaneous procedures including transcatheter aortic valve replacement, endovascular aortic repair, ventr...
Source: Mass Device - July 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Vascular Essential Medical Devices Source Type: news

Lombard expands EU launch of Altura AAA endograft system
Lombard Medical Technologies (NSDQ:EVAR) said today it expanded the European launch of its Altura endovascular stent graft to the Netherlands and Spain, touting 4 completed procedures with the device in the newly expanded regions. The Altura endograft system is designed as a transcatheter treatment for abdominal aortic aneurysms, and can be repositioned during deployment to allow for the utilization of the available aortic neck, the company said. “We’ve been very encouraged by our momentum since launching Altura in the UK and Germany in late February, and we’re delighted to be expanding the roll...
Source: Mass Device - July 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular Lombard Medical Technologies Source Type: news

Lombard touts 1st commercial use of IntelliFlex LP with Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) today touted the 1st commercial use of its IntelliFlex low profile delivery system designed to implant the Aorfix endovascular stent graft in a procedure to treat an abdominal aortic aneurysm. The procedure was performed by Dr. Nilo Mosquera at Spain’s Complexo Hospitalario Universitario de Ourense on the 28th of June, the Irvine, Calif.-based company said. “My surgical team and I were very pleased with the performance of IntelliFlex LP. The device’s lower catheter profile was able to successfully navigate this particular patient’s calcified access vesse...
Source: Mass Device - July 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Stent Grafts Surgical Lombard Medical Source Type: news

Lombard Medical wins CE Mark for Aorfix AAA stent graft delivery device
Lombard Medical Technologies (NSDQ:EVAR) said today it won CE Mark approval in the European Union for its IntelliFlex low profile delivery system for its Aorfix endovascular stent graft. The system is designed for the delivery of the company’s abdominal aortic aneurysm Aorfix endovascular stent graft, and includes an integrated exchange sheath designed for the delivery of ancillary devices during the procedure, the company said. The design removes the need for catheter exchanges, which Lombard said saves procedure time, blood loss and possible vessel trauma. “The 1st-in-man procedure with the new IntelliFl...
Source: Mass Device - June 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular Lombard Medical Technologies Source Type: news

Lombard touts 5-year Aorfix stent graft data
Lombard Medical Technologies (NSDQ:EVAR) yesterday released 5-year results from the Pythagoras trial of its Aorfix, which aimed to evaluate the safety and effectiveness of the stent graft in treating highly angulated aortic necks or tortuous aortoiliac anatomy. A presentation based on data from the study was presented at the 2016 Society for Vascular Surgery’s annual meeting in National Harbor, Maryland this week, the company said. A total of 87% of surviving patients in the 218 patient trial were followed-up with at 5 years, Lombard said, with 60% of angled neck patients showing significant aneurysm sac shrinka...
Source: Mass Device - June 14, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Lombard Medical Source Type: news

Gore wins CE Mark for Excluder stent graft
W.L. Gore & Associates said today it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging anatomies. The newly cleared Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic neck length of 10 mm, the Newark, Del.-based company said. “With the Gore Excluder Conformable Device, our EVAR solutions will offer the broadest treatment range of any supplier in the market. The feedback received on this new product suggests a high level of interest from physi...
Source: Mass Device - June 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Stents Surgical Vascular W.L. Gore & Associates Source Type: news

MVM Life Science Partners closes $233m healthcare fund
MVM Life Science Partners said it plans to use the $233 million it raised for its 4th fund to invest in medical companies in the U.S. and Europe. The Boston-and-London-based investment shop said the fund is its largest so far. MVM said it backs public and private companies at every stage of development, with investments of between $15 million and $30 million per company. “We have had a very positive response from investors and we are delighted with the group of investors we have been able to attract,” founder & managing partner Dr. Stephen Reeders said in prepared remarks. “We...
Source: Mass Device - May 3, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Wall Street Beat MVM Life Science Partners Venture Capital/Private Equity Source Type: news

Evar Guidance Engine Software Makes Work Easier for Surgeons
At the Charing Cross Congress in London, Siemens Healthcare presents the Evar Guidance Engine software application package to support minimally invasive treatment of aortic aneurysms. This is the first application package that enables an automated workflow for stent placement with fusion imaging. (Source: eHealth News EU)
Source: eHealth News EU - April 29, 2016 Category: Information Technology Tags: Featured Siemens Business and Industry Source Type: news

Medtronic touts Endurant stent graft data, lowered mortality
Medtronic (NYSE:MDT) today released data from the Engage global registry study of its Endurant abdominal aortic aneurysm stent graft, touting lowered mortality and rupture rates compared to the earlier Evar 1 trial. Data from the studies was presented at the 2016 Charing Cross Symposium in London, Fridley, Minn.-based Medtronic said. “In the comparison analysis of Engage and Evar 1 we can see just how far our medical advancements have come in improving patient outcomes with Evar. The very well-structured Evar 1 gave us the opportunity to understand the urgent need of improvement in Evar, especially in mid- ...
Source: Mass Device - April 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Medtronic Source Type: news

Thoracic aortic endovascular repair in a twin-pregnant patient following motor vehicle crash - Al-Thani H, Barah A, AlMulla A, Hussein A, El-Menyar A.
[Abstract unavailable] Language: en... (Source: SafetyLit)
Source: SafetyLit - April 27, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Lombard rises on prelims, expanding EU sales force and US drill down
Lombard Medical Technologies (NSDQ:EVAR) yesterday released preliminary estimates for its Q4 and fiscal year 2015, off slightly from estimates but shares rose with the news. The Irvine, Calif.-based company reported preliminary revenue of $2.9 million for the quarter and $15.1 million fro the full year – a growth of 14% from last year, but off of Wall Street analyst expectations by a few hundred thousand in both. Shares, however, have been rising today, up over 10% to 85¢ as of 3:59 p.m. EST. Lombard also announced it is increasing the size of its direct sales force in Germany and the UK to support the...
Source: Mass Device - January 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Lombard Medical Technologies Source Type: news

Cordis touts 4-year data on Incraft AAA stent graft
Cordis Corp. said today that 4-year data from a trial of its Incraft abdominal aortic aneurysm stent graft system showed it “performed well” in patients suffering from AAAs 4 years after treatment. Data from the study was presented at the VEITHsymposium in New York City this week. The multi-center, open-label prospective Innovation trial reported a 97% freedom from endoleaks and no stent graft migrations after 4-years. “With the 4-year study results demonstrating continued performance with the Incraft System in Europe, Cordis’ device is clinically established in a class of next-genera...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Stent Grafts Cardinal Health Cordis Corp. Source Type: news

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 i...
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 Ti...
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 ...
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 remark...
Source: Mass Device - September 24, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Bolton Medical Source Type: news