SurModics wins FDA nod for low-profile PTA balloon dilation catheter
SurModics (NSDQ:SRDX) said yesterday it won FDA 510(k) clearance for its .018″ low-profile percutaneous transluminal angioplasty balloon dilation catheter designed for peripheral vascular use.
The newly cleared low-profile catheter features the Eden Prairie, Minn.-based company’s low-friction, low-particulate Serene hydrophilic coating with a range of between 2mm to 10mm.
“We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular SurModics Inc. Source Type: news
Surmodics Announces FDA Clearance of a New .018 " Low-Profile PTA Balloon Dilation Catheter
Company received FDA 510(k) clearance Continued progress in R&D whole-product solutions pipeline EDEN PRAIRIE, Minn.--(BUSINESS WIRE)-- Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad...This story is related to the following:Catheters (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - April 24, 2018 Category: Medical Devices Source Type: news
Can New Indication Give Medtronic Edge in DCB?
Medtronic is entering a bold new chapter in the continued evolution of its drug-coated balloon technology (DCB). The Dublin-based firm said on Monday, that it received a nod from FDA for the IN.PACT Admiral DCB to treat long superficial femoral artery (SFA) lesions up to 360mm in patients suffering from peripheral artery disease (PAD).
Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, including long lesion, in-stent restenosis, and chronic total occlusion groups with lesion lengths greater than 180mm.
Across these groups, a total of 227 subjects with mean lesion le...
Source: MDDI - April 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Surmodics Announces FDA Clearance of a New .018 Low-Profile PTA Balloon Dilation Catheter
Company received FDA 510(k) clearance
Continued progress in R&D whole-product solutions pipeline
EDEN PRAIRIE, Minn. -- (Healthcare Sales & Marketing Network) -- Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologi... Devices, Interventional, FDA Surmodics, percutaneous transluminal angioplasty, balloon catheter (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 23, 2018 Category: Pharmaceuticals Source Type: news
Intact Vascular raises $20m in Series C
Intact Vascular said today it raised $20 million in a Series C round of financing, with funds slated to support the company’s Tack endovascular system through the FDA pre-market approval process.
The round was joined by major participants New Enterprise Associates, H.I.G. BioVentures and Quaker Partners, the Wayne, Penn.-based company said. The funding is slated to come in two stages or tranches, with the second closing later this year.
Late last week, the company posted an SEC filing showing that it had raised $10 million in a round of mixed financing, and that it was seeking an additional $11.8 million before closi...
Source: Mass Device - April 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Wall Street Beat Intact Vascular Source Type: news
Intact Vascular raises $10m, looks to raise $12m more
Intact Vascular has raised $10 million in a new mixed round of financing, according to an SEC filing posted this week.
Money in the round comes from 3 anonymous investors, with the first sale noted on April 5, according to the filing.
The company has not yet officially stated how it plans to spend the funds, but noted that $2.1 million of the proceeds will be used to pay its executive officers, directors or promoters.
Intact Vascular is looking for an additional $11.8 million in the round to close out at $21.8 million, according to the filing.
Last July, Intact Vascular announced the European launch of the Toba II BTK clin...
Source: Mass Device - April 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Intact Vascular Source Type: news
Intact Vascular Has a Unique Way to Treat PAD Patients
Intact Vascular is hoping to have a below-the-knee (BTK) indication for its Tack Endovascular System in 2020 company executives, told MD+DI. Data from the Tack Optimized Balloon Angioplasty Below the Knee (TOBA BTK) clinical trial, an initial study of the technology, was published in the current issue of Catheterization and Cardiovascular Intervention. The published data could help pave the way for an approval.
The Tack Endovascular System is an implant for the precision dissection repair following balloon angioplasty and received CE mark in 2012. The device is designed to help maintain vessel integrity and improve bloo...
Source: MDDI - March 27, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
Contego Medical launches Neuroguard IEP trial
Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis.
The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said.
“We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a ...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Contego Medical Source Type: news
Backlash Over Nixing of CMS Add-On Payments for DCBs
(MedPage Today) -- Superiority of drug-coated balloon angioplasty not reflected in reimbursement, group suggests (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 5, 2018 Category: American Health Source Type: news
Medtronic ’ s In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis
Medtronic (NYSE:MDT) touted data today from a two-year study of its In.Pact Admiral drug-coated balloon in patients with peripheral artery disease in Japan, as well as the results from a critical limb ischemia subgroup analysis from its In.Pact Global trial.
The company’s In.Pact SFA Japan study enrolled 100 patients and randomized them to receive either the drug-coated balloon or plain balloon angioplasty.
Get the full story at our sister site, Drug Delivery Business News.
The post Medtronic’s In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis appeared first on Mas...
Source: Mass Device - January 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Pharmaceuticals Wall Street Beat Medtronic Source Type: news
FDA Again Warns on Balloon Angioplasty for Neurologic Disorders
(MedPage Today) -- Says transvascular autonomic modulation is off-label and dangerous (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - December 26, 2017 Category: Primary Care Source Type: news
Bringing Robotics into the Cath Lab to Protect Physicians
Percutaneous Coronary Intervention (PCI, or angioplasty with stent) is a common procedure used to treat patients with obstructive coronary artery disease, with an estimated 600,000 procedures performed annually in the United States. PCI has a low risk of complications for patients, but that's not the case for clinicians.
Patients receive a dose of radiation during a PCI procedure, which takes anywhere from 30 minutes to a few hours. Interventional cardiologists and cardiac catheterization laboratory personnel are exposed to ionizing radiation all day, every day. Protective measures, such as radiation safety caps, goggles...
Source: MDDI - December 15, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: Medical Device Business Source Type: news
7 medtech stories we missed this week: Dec. 8, 2017
[Image from unsplash.com]From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning.
1. Minimus Spine inks EU distribution deal
Minimus Spine announced in a Dec. 4 press release that it has signed its first European distribution deal with Italian company Moss and has completed its first commercial order. Moss has exclusive distribution rights to distribute in Italy, Germany, Switzerland and the U.K.
2. Elanix, Dermacon sign wound management development deal
Elanix Biotechnologies and Dermacon have si...
Source: Mass Device - December 8, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiac Assist Devices Cardiovascular Diagnostics Food & Drug Administration (FDA) Hospital Care Pain Management Regulatory/Compliance Cagent Vascular CSA Medical Inc. Dermacon Elanix Life Spine Inc. MedTech Minimus Spin Source Type: news
Cordis Comes Back for Another Stent
Cordis is getting back into the coronary stent game. The company, which is now owned by Cardinal Health, landed exclusive rights to sell Medinol's coronary stent portfolio in the U.S.
Milpitas, CA-based Cordis is already selling Medinol's NIRxcell cobalt-chromium bare-metal stent and, assuming FDA approves Medinol's EluNIR drug-eluting stent (DES), Cordis will distribute it as well. Medinol is based in Israel.
In addition to the Medinol agreement, Cordis recently launched the Tryton Side Branch Stent and two percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. The Medinol agreement, along with the avai...
Source: MDDI - October 31, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news
Andreas Roland Gruentzig, the Man Andreas Roland Gruentzig, the Man
A fascinating profile of Andreas Gruentzig, the renowned cardiologist who first developed balloon angioplasty, and is considered the father of modern-day percutaneous coronary intervention.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 26, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
