Medtronic touts 3-year Heli-FX EndoAnchor registry study data
Medtronic (NYSE:MDT) today released three-year data from the Anchor registry study of its Heli-FX EndoAnchor system, touting that it indicated the system is safe, efficient and durable in treating patients with complex aortic abdominal aneurysm anatomy, specifically those with hostile aortic neck anatomies. Results from the trial were presented by co-principal investigator Dr. William Jordan of the Emory University School of Medicine at the 45th Annual Symposium of Vascular and Endovascular Issues in New York, the Fridley, Minn.-based company said. “Hostile aortic necks are frequently seen in clinical practice a...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Vascular Medtronic Source Type: news

FDA approves Medtronic ’ s Valiant Navion thoracic stent graft
Medtronic (NYSE:MDT) said today that it won FDA approval for its Valiant Navion thoracic stent graft system intended for use in the minimally invasive repair of lesions in the descending thoracic aorta. The Fridley, Minn.-based company said that the stent system is now cleared for use in procedures to repair thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and aortic type B dissections. Medtronic said that the newly cleared Valiant Navion stent will enable patients with small iliac arteries to undergo thoracic endovascular aneurysm repairs, and will open pe...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance Stent Grafts Stents Vascular Medtronic Source Type: news

FDA: Endologix recall of AFX stent graft is Class I
Endologix (NSDQ:ELGX) said late last week that the FDA classified its voluntary recall of AFX Endovascular abdominal aortic aneurysm stent graft systems as Class I. 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 Irvine, Calif.-based company said it issued its recall action in July, sending safety notices to healthcare professionals who use the system. The notice included updated information on comparative Type III endoleak rates associated with the device, ...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Recalls Regulatory/Compliance Vascular Endologix Source Type: news

Gore ’s aneurysm device for tricky anatomies implanted in Europe
(Image courtesy of W.L. Gore & Associates) The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates. The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles of up to 90 degrees with a minimum 15 mm aortic neck length and patients with proximal aortic neck angles of up to 60 degrees with a 10 mm minimum aortic n...
Source: Mass Device - September 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Implants Surgical W.L. Gore & Associates Source Type: news

Gore Wins 3 Nods for Molding and Occlusion Balloon
W.L. Gore & Associates has won approvals and clearances from a wide variety of regulatory bodies for its Molding and Occlusion Balloon. The technology has received FDA clearance; a CE mark; and approval from the Japanese Ministry of Health, Labour, and Welfare. The Flagstaff, AZ-based company’s device is a compliant polyurethane balloon catheter. The Molding and Occlusion Balloon was designed in close collaboration with clinicians to assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels. Gore said the new device meets all endovascular aortic repair (EV...
Source: MDDI - August 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Gore touts regulatory wins for new balloon catheter
W.L. Gore & Assoc. said today that its molding & occlusion balloon won a trifecta of regulatory nods in the U.S., Japan and Europe. The Flagstaff, Ariz.-based company said the device is designed to deliver stent grafts or temporarily occlude large-diameter vessels during endovascular aortic repair procedures. In addition to 510(k) clearance from the FDA, the balloon won CE Mark approval in the European Union and a  nod from Japan’s Ministry of Health, Labor & Welfare. It’s designed to be compatible both with Gore’s Excluder stent graft and any future such devices Gore puts on the mar...
Source: Mass Device - August 23, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Regulatory/Compliance Stent Grafts W.L. Gore & Associates Source Type: news

Declining Sales Prompts Endologix to Hit the Strategic Reset Button
John Onopchenko has had his work cut out for him since being promoted to CEO of Endologix in May. The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016 after a manufacturing glitch interrupted sales of its top-selling device for abdominal aortic aneurysms (AAA). This and other issues led CEO John McDermott to resign earlier this year. "The leadership team and I have been working hard on reestablishing Endologix's credibility and reputation with our physicians and customers and building a culture of accountability, with the ultimate goal of deliv...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Cath Lab Recap: TAVR MEDCAC; ICA Calcified in Kids; Fenestrated EVAR
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - July 26, 2018 Category: Neurology Source Type: news

Out with the Old, in with the ... Newish?
  It takes a strong leader to admit when his time is up. Endologix CEO John McDermott is that type of leader, which he proved this week with the announcement that he will be stepping down as CEO of the struggling endovascular aneurysm repair (EVAR) company.     Endologix has had its fair share of hurdles over the past couple of years, but it seems like things might finally be looking up for the Irvine, CA-based company. In May, the company promoted John Onopchenko to the role of CEO. Prior to the promotion, Onopchenko was the company's chief operating officer, a p...
Source: MDDI - July 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

MicroPort < sup > ® < /sup > NeuroTech Hosts Intracranial Vascular Endovascular Repair Summit
(Source: Microport News Release)
Source: Microport News Release - June 29, 2018 Category: Medical Devices Source Type: news

Endologix reports 1-year data from Ovation registry
Endologix (NSDQ:ELGX) this week touted 1-year results from its Lucy registry – a study that prospectively assessed endovascular aneurysm repair outcomes in women compared to men. The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system compared to other EVAR systems. The study enrolled 225 people, 76 women in the treatment group and 149 men in the control group, and the primary endpoint was the 30-day major adverse event rate. Secondary endpoints included serious and non-...
Source: Mass Device - June 28, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Vascular Women's Health Endologix 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 limi...
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

Endologix promotes COO to corner office, posts mixed Q1 results
Endologix (NSDQ:ELGX) promoted chief operating officer John Onopchenko to CEO just in time for him to take the lead on the company’s first-quarter financial results. Onopchenko served as the Irvine, Calif.-based company’s COO for the past seven months. He has spent 30 years in the medical device industry, including nearly a decade at Johnson & Johnson (NYSE:JNJ), where he led medical device investments and worldwide operations for the company’s advanced sterilization products unit. “Since joining the company as COO, I have been deeply involved in the operations of the organization, and...
Source: Mass Device - May 4, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: MassDevice Earnings Roundup Stent Grafts Vascular Wall Street Beat Endologix johnsonandjohnson Source Type: news

LivaNova closes $190 CRM sale to MicroPort
LivaNova (NSDQ:LIVN) said today that it closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853). The companies are already partners in a CRM join venture in the People’s Republic. LivaNova, formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, said in September that it was putting the CRM business on the auction block. The business pulled in sales of $249 million last year. After announcing its plans for the divestiture last November, LivaNova said the details of the sal...
Source: Mass Device - April 30, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Mergers & Acquisitions Wall Street Beat Cardiac Rhythm Management LivaNova MicroPort Scientific 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 Brazi...
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

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 desig...
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

Things Are Finally Looking Up for Endologix
Endologix has had a rough couple of years, but things are finally beginning to look up for the Irvine, CA-based company. Earlier this month the company enrolled the first patient in a confirmatory study of its next-generation Nellix endovascular aneurysm sealing system, an important step toward eventually getting that technology to the U.S. market. The good news continues this week with positive results from a pooled analysis of studies evaluating the company's Ovation product line. Ovation, a next-generation endovascular aneurysm repair (EVAR) system that uses polymer to help physicians create a customized seal between th...
Source: MDDI - March 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business 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 o...
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

Endologix CEO: It & #039;s Time for a Leadership Change
It takes a strong leader to admit when his time is up. Endologix CEO John McDermott is that type of leader, which he proved this week with the announcement that he will be stepping down as CEO of the struggling endovascular aneurysm repair (EVAR) company. "The past couple of years have been difficult for the company, employees, and investors, so it's time for a leadership change," McDermott said during the company's fourth-quarter earnings call, according to Seeking Alpha transcripts. McDermott has been at the Irvine, CA-based company for nearly 10 years. He said he will continue in his role until the board ...
Source: MDDI - February 22, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Radiation-Induced DNA Damage in Operators Performing EVAR Radiation-Induced DNA Damage in Operators Performing EVAR
Radiation exposure during fluoroscopically guided procedures is a growing concern. Should operators performing EVAR be worried?Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 13, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Is This Struggling EVAR Player on Its Last Leg?
Lombard Medical Technologies could be standing on its last leg. The company disclosed in a filing with the U.S. Securities and Exchange Commission that it has defaulted on a loan and expects to go broke in the first half of this year. The Didcot, England-based company said it met with Oxford Finance representatives Jan. 8 to discuss the company's current financial situation. Four days later, Lombard received a default notice from the lender. The company said it is working with Oxford to try to restructure its debt, but according to the current terms of its loan agreement, Oxford may pursue all available remedies ...
Source: MDDI - January 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Strapped for cash, Lombard Medical defaults on loan
Strapped for cash, Lombard Medical Technologies (NSDQ:EVAR) said last week that it received a default notice from one of its lenders. The Didcot, U.K.-based stent graft maker said Oxford Finance sent the default letter Jan. 12, four days after meeting with Lombard to discuss its finances. To make matters worse, Lombard said it doesn’t have enough cash on hand to make it past the first half of the year. “[U]nless additional financing becomes available, the company expects to exhaust its current cash resources in the period between Q1 2018 and Q2 2018,” the company said in a regulatory filing. “T...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Stent Grafts Wall Street Beat Lombard Medical Source Type: news

Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study. The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee. “Patients with extreme proximal neck anatomies often do not qualify for EVAR. Regardless of device flexibility, current delivery systems make it difficult to achieve conformability during deployment. The angulation control in the new delivery system for the Gore Excluder Co...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular W.L. Gore & Associates Source Type: news

Endovascular Repair of Abdominal Aortic Aneurysm Endovascular Repair of Abdominal Aortic Aneurysm
How might endovascular aneurysm repair benefit patients with abdominal aortic aneurysm who are physically frail and ineligible for open repair?Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 15, 2017 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news

Endovascular Repair of Ruptured AAA Improves Midterm Survival Endovascular Repair of Ruptured AAA Improves Midterm Survival
Endovascular repair of ruptured abdominal aortic aneurysm was linked to reduced mortality at 3 years, improved early quality of life, and reduced costs compared with open surgery in the IMPROVE trial.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 20, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

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