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-pro...
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 confident...
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 treatment for an...
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, ventricular assis...
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 rollout into the Net...
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 vessels, somethin...
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 IntelliFlex d...
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 shrinkage. ...
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 believe the fund raising was he...
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- and long...
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 European la...
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-generation AAA dev...
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
