Could Better Materials Lead to Better Outcomes with DCBs?
Boston University School of Medicine (BUSM) researchers are examining drug-coated balloon catheters at a microscopic level in hopes of producing more efficient alternatives for treating arterial disease. The researchers are specifically looking at the coatings of the devices. Obstructive arterial disease is a clinical challenge affecting millions of people in the world. Devices such as stents and balloon catheters are the primary choice for treating these narrowed vessels. While the use of stents is beneficial in many cases, once implanted, they remain in the body permanently. Presence of such foreign bodies inside an arte...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Materials Source Type: news

FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 15, 2019 Category: Health Management Authors: John George Source Type: news

FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2019 Category: Biotechnology Authors: John George Source Type: news

FDA approves Intact Vascular ’ s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news

Is the Paclitaxel Narrative Getting Worse?
Paclitaxel drug-coated balloons and drug-eluting stents received some bad press in January after a meta-analysis showed an increased risk of death for patients treated with these devices in the femoral and/or popliteal arteries of the lower limbs. Two drug-eluting device trials were paused after the analysis was published in the Journal of the American Heart Association and the data prompted FDA to investigate. Mike Matson, a medtech analyst at Needham & Co., issued a report in February pointing to evidence and expert opinion that the benefits of using paclitaxel balloons and stents outweigh the risks. Now,...
Source: MDDI - March 13, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Regulatory/Compliance Wall Street Beat Medtronic Source Type: news

Drug-Coated Balloons Superior After 5 Years in PAD
(MedPage Today) -- Paclitaxel balloon found superior in keeping leg arteries open compared with plain angioplasty (Source: MedPage Today Radiology)
Source: MedPage Today Radiology - February 2, 2019 Category: Radiology Source Type: news

Study of VentureMed ’ s Flex catheter begins in Switzerland
Vascular-focused device developer VentureMed said yesterday that it has launched another study of its Flex dynamic scoring catheter, this one to measure how open patients’ blood vessels remain 12 months after treatment. The prospective, single arm, non-randomized study in Switzerland will enroll up to 150 patients whose superficial femoral and popliteal arteries were scored by the Flex system before drug-eluting balloon angioplasty. Flex creates long, parallel, linear micro-incisions in all plaque-lined arteries. Dr. Daniel Périard and Dr. Rolf Engelberger, both of the angiology department at HF...
Source: Mass Device - January 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog News Well Research & Development Vascular internationalsymposiumonvasculartherapy venturemed Source Type: news

Will Drug-Eluting Devices Suffer from JAHA Publication?
A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA). Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD ...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news

FDA clears Contego Medical ’ s Vanguard IEP peripheral balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function. “Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues to expand and become more complex, we believe our technology will play a critical role in protecting vulnerable patients from embolic events and thus improve procedural outcomes.” “The Vanguard IEP System is design...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Featured Food & Drug Administration (FDA) Regulatory/Compliance Contego Medical peripheral Source Type: news

Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
RALEIGH, N.C., Dec. 7, 2018 -- (Healthcare Sales & Marketing Network) -- Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Int... Devices, Interventional, FDA Contego Medical, Vanguard IEP, Peripheral, Angioplasty, embolic protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 7, 2018 Category: Pharmaceuticals Source Type: news

Philips Takes a Firm Stand in the DCB Market with ILLUMENATE
This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation." Layout of the Land C.R. Bard once held the crown in the DCB market, having gained approval for its Lutonix technology in 2014. The Murray Hill, NJ-based company began losing share when Medtronic launched the IN.PACT Admiral in early 2015. (Ed...
Source: MDDI - November 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon. The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia. Get the full story at our sister site, Drug Delivery Business News. The post Philips launches below-the-knee PAD trial for drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Royal Philips Source Type: news

5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
At last week's Vascular Interventional Advances (VIVA) Annual Meeting in Las Vegas, Medtronic presented five-year final outcomes from its IN.PACT SFA Trial. Of note: Medtronic is the first company to present long-term five-year outcomes for a commercially-available drug-coated balloon (DCB). The data not only reinforced the safety, durability, and efficacy of the IN.PACT Admiral DCB, as seen in previous studies, but also reaffirmed its use as a frontline therapy for the treatment of peripheral artery disease (PAD). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 13, 2018 Category: Cardiology Source Type: news

Trial shows BD balloon compares well with angioplasty for CLI
BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee. The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb through 30 days—was met in both the proportional and binary and Kaplan Meier analyses of patient survival following a medical procedure. BD presented the trial results during a l...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Catheters Clinical Trials Featured Research & Development Vascular BD Vascular Interventional Advances (VIVA) Source Type: news

VentureMed launches Flex scoring catheter study
Vascular focused device developer VentureMed said yesterday that it launched a new study of its Flex dynamic scoring catheter, exploring whether the device reduces dissections and the need for bailout stents in peripheral arteries. In the newly launched iDissection Classification study, investigators will use intravascular ultrasound to identify the health of vessels after treatment with the Flex system, the Toledo, Ohio-based company said. The trial is being led by Dr. Nicolas Shammas of Davenport, Iowa’s Midwest Cardiovascular Research Foundation, who led the previous iDissection study. In the previous st...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Vascular venturemed Source Type: news

Intact Vascular Has Strong Data from TOBA II
One-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) successfully achieved both its primary and secondary endpoints. The Wayne, PA-based company announced the results at the 15th annual VIVA conference in Las Vegas. The company said this is the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disea...
Source: MDDI - November 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

New Data for IN.PACT Drug-Coated Balloon Show Sizable Advantage Over Standard PTA in Peripherals
Dual presentations, made at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings in San Diego and Lisbon, showed significant superiority of Medtronic's IN.PACT Admiral drug-coated balloon (DCB) over standard Percutaneous Transluminal Angioplasty (PTA). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 3, 2018 Category: Cardiology Source Type: news

Ra Medical sets range for $50m IPO
Ra Medical yesterday set the terms for its forthcoming initial public offering, which would fetch $50 million at the midpoint. The Carlsbad, Calif.-based company said it plans to float 3.3 million shares at $14 to $16 apiece, for gross proceeds of $46.7 million to $53.3 million. At the midpoint the flotation would gross $50.0 million, according to a new filing with the U.S. Securities & Exchange Commission. That’s well below the more than $86 million Ra Medical indicated in a regulatory filing last month. The company makes the Dabra atherectomy catheter laser to treat patients with peripheral artery disease....
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Funding Roundup Initial Public Offering (IPO) Wall Street Beat peripheral Ra Medical Source Type: news

FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection. Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January. A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said. “We are thrilled to have achieved this milestone for the first of several device...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news

Ra Medical re-ups $86m IPO registration
Ra Medical has re-upped its registration for an upcoming initial public offering looking to bring in approximately $86.3 million, according to a recently posted SEC filing. Ra Medical produces the Dabra atherectomy catheter laser designed to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the company touts as having significant advantages over traditional balloon angioplasty systems. Ra Medical won FDA 510(k) clearance for the system last May, and CE Mark approval in the European Union in 2016. The C...
Source: Mass Device - August 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Ra Medical Source Type: news

Ra Medical registers for $87m IPO
Ra Medical yesterday registered for an initial public offering worth up to $86.5 million, according to a recently posted SEC filing. The Carlsbad, Calif.-based company said it plans to list on the New York Stock Exchange under the symbol “RMED,” according to the SEC posting. Piper Jaffray and Cantor Fitzgerald are acting as joint book runners for the offering, according to the filing. Ra Medical produces the Dabra atherectomy catheter laser designed to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Ra Medical Source Type: news

Cagent Vascular closes $12m Series B
Cagent Vascular said today it closed a $11.9 million Series B round of financing to help support expand manufacturing and a limited launch of the company’s Serranator Alto angioplasty device. The round was led by two strategic investors and joined by Balestier Investments, Ben Franklin Technology Partners, Synergy Ventures and other private investors, the Wayne, Penn.-based company said. Cagent Vascular’s Serranator is an angioplasty device that uses serrated metal strips on a semi-complaint balloon to create multiple longitudinal lines of micro-serrations within the luminal surface to aid in arterial expa...
Source: Mass Device - July 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Cagent Vascular Source Type: news

FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical
The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical. The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; TVA Medical makes the EverlinQ EndoAVF system. “Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodial...
Source: Mass Device - June 22, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Dialysis Food & Drug Administration (FDA) Regulatory/Compliance Avenu Medical TVA Medical Source Type: news

Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB
QT Vascular said today it inked a deal to sell its non-drug coated coronary products to Teleflex (NYSE:TFX), including its Chocolate XD and Glider, with an option to purchase its Chocolate Heart drug-coated coronary balloon catheter which is currently under development. Singapore-based QT Vascular has not released any financial details of the deal, but said that it will continue to develop and market its other products, including its Chocolate Touch drug-coated percutaneous transluminal angioplasty balloons. The company said it is currently enrolling patients in an IDE trial of the Chocolate Touch device. Re...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Drug-Device Combinations Vascular QT Vascular Teleflex Source Type: news

Boston Scientific touts safety, effectiveness in Rhythmia mapping study
Boston Scientific‘s (NYSE:BSX) Rhythmia mapping system and catheter was found to be safe and effective in procedures to treat arrhythmias, according to a Healio summary of a newly released study from the company. Researchers in the study examined 572 patients, with 519 patients undergoing procedures with the Rhythmia system and IntellaMap Orion catheter, according to the report. A total of 504 patients had a complete mapping procedure and were followed for one month post-procedure. Findings from the study were presented at the EHRA 2018 meeting, according to Healio. The primary endpoint of the trial was acute procedu...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Imaging Boston Scientific Source Type: news

Boston Scientific ’s drug-coated balloon succeeds in femoropopliteal segment at one year
Data from Boston Scientific‘s (NYSE:BSX) Ranger SFA trial showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty. The results, which were published this month in JACC: Cardiovascular Interventions, demonstrated that both groups of patients – those treated with Boston Scientific’s Ranger DCB and those treated with standard balloon angioplasty – experienced similar quality-of-life improvements over the course of 12 months. Get the fu...
Source: Mass Device - May 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Pharmaceuticals Wall Street Beat Boston Scientific Source Type: news

SurModics acquires Embolitech thrombectomy tech for $5m
SurModics (NSDQ:SRDX) said today it inked a deal with Embolitech to acquire its thrombectomy platform the and associated intellectual property in a deal worth $5 million up front, with additional payments based on regulatory milestones. The newly acquired tech platform is designed for use in the peripheral vasculature to remove hard blood clots, Eden Prairie, Minn.-based SurModics said. SurModics added that it plans to leverage its design, development and manufacturing capabilities to advance the platform into different peripheral and vascular applications. “We are pleased to sign an agreement with Surmodic...
Source: Mass Device - May 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Mergers & Acquisitions Vascular SurModics Inc. Source Type: news

7 medtech stories we missed this week: May 11, 2018
[Image from unsplash.com]From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of the Therapeutic Products Directorate in Canada to amend its existing Canadian medical device license to include distribution of the ReShape Balloon and its accessories. The ReShape Balloon is FDA approved and is a non-s...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Hospital Care Imaging mHealth (Mobile Health) Neurological Patient Monitoring Regulatory/Compliance Brainsway Conavi Exact Imaging innovativehealth MedTech PeraHealth qtm Source Type: news

U.S. Drug-Coated Balloons Market Threatened by Reimbursement Cuts and Competitive Pressure
Conclusion Launched in late 2014, DCB sales exploded in 2015, following the establishment of the TPT payment. Rapid growth persisted through 2016 and 2017, fueled by favorable reimbursement, strong clinical results, and new indications for ISR, long lesions, and AV access. The expiration of the TPT payment threatens to cause DCB unit sales and ASPs to contract in 2018. The DCB space is fiercely competitive, and market leaders Medtronic and C. R. Bard are constantly refining their respective DCB portfolios to gain the edge in the high-profile market. Spectranetics threw its hat in the ring in 2017, but is yet to make a subs...
Source: MDDI - May 7, 2018 Category: Medical Devices Authors: Sean Collins and Kamran Zamanian Tags: Business Source Type: news

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&rsq...
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 l...
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 impr...
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 inclu...
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...
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,...
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...
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 ...
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

7 medtech stories we missed this week: Sept. 22, 2017
[Image from unsplash.com]From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion si...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Diagnostics Food & Drug Administration (FDA) Laboratory Instruments/Laboratory Supplies mHealth (Mobile Health) Research & Development Vascular Bioventus LLC Contego Medical Covalon Technologies Getinge Guerbe Source Type: news

Surmodics Announces Global Approvals of .014 & #226; �? Low-Profile PTA Balloon Dilation Catheter
The company received FDA 510(k) and CE Mark clearance EDEN PRAIRIE, Minn. - Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product...This story is related to the following:Catheters (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - September 19, 2017 Category: Medical Devices Source Type: news

SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath
SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months. The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction and particulates, the Eden Prairie, Minn.-based company said. SurModics said the clearance and coming launch of the low-profile PTA cath is a continuation of the company’s strategy to supply whole-product vascular solutions. ...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular SurModics Inc. Source Type: news

7 medtech stories we missed this week: Sept. 15, 2017
[Image from unsplash.com]From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to lead its Restrata wound matrix study. The study will surgery the clinical outcomes of Restrata treatments for diabetic foot ulcers and test for effectiveness and safety. Restrata is a fully synthetic wound matrix that is FDA-cleared for ...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Dental Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Surgical Acera Surgical Contego Medical Fresenius MedTech OBP Medical Pinnacle Sciences Plusoptix Telos Source Type: news

Japan approves Medtronic ’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The In.Pact Admiral DCB has demonstrated superior one-year clinical outcomes in Japan and across Medtronic In.Pact SFA clinical trials, providing patients with an improved restoration of blood flow and reduced need for additional revasc...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Medtronic Source Type: news