Do You Know How to Manage Japan ’s Revised Reimbursement Approach?
One significant change in Japan’s revised reimbursement process for new medical devices involves pricing. Applicants have been required for some time to provide pricing for their medical devices in other primary markets such as the United States, the United Kingdom, Germany, France, and Australia. Pricing has been based on list price, not market price, and the intention was to cap the reimbursement of medical devices. Given the typical differences between U.S. pricing and European pricing, the high U.S. price tended to pull the average up. (Please see the example below in Table 1; each price is converted ...
Source: MDDI - July 27, 2018 Category: Medical Devices Authors: Keisuke Suzuki Tags: Regulatory and Compliance Source Type: news

Five-Year Stroke Rates Lower After PCI Versus CABG
WEDNESDAY, July 18, 2018 -- Stroke rates are lower at 30 days and five years after percutaneous coronary intervention (PCI) than after coronary artery bypass grafting (CABG), according to a study published in the July 24 issue of the Journal of the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 18, 2018 Category: Pharmaceuticals Source Type: news

PCI patients discharged against medical advice twice as likely to be readmitted
(American College of Cardiology) In a new study, researchers found discharge against medical advice as the strongest predictor of 30-day unplanned readmissions in heart attack patients. While only a small number of patients choose to discharge against medical advice following percutaneous coronary intervention (PCI), these patients are twice as likely to be readmitted to the hospital, according to the study published in JACC: Cardiovascular Interventions. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 18, 2018 Category: International Medicine & Public Health 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

Icing a strained muscle reduces damage – even your heart: Cooling it after a heart attack reduces swelling, damage by 20-30%
(Natural News) Localized cooling of the heart before and after angioplasty may help mitigate the risk of further cardiovascular damage during a heart attack, a recent study carried out by Netherlands-based cardiologists revealed. According to experts, heart attack patients were at an increased risk of cardiovascular muscle death. Cardiologists prevented this by performing angioplasty procedure, where the constricted... (Source: NaturalNews.com)
Source: NaturalNews.com - July 14, 2018 Category: Consumer Health News Source Type: news

Video: Carotid angioplasty and stenting
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - July 14, 2018 Category: Consumer Health News 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

Asahi Intecc to buy RetroVascular for $26m
Asahi Intecc said early this month that its board of directors agreed to acquire RetroVascular in a deal worth approximately $25.9 million. Menlo Park, Calif.-based RetroVascular is developing cardiological tools for percutaneous transluminal coronary angioplasty procedures, specifically to treat chronic total occlusions. Asahi said that it has maintained a collaborative relationship with RetroVascular to develop the PTCA treatment, which incorporates the use of plasma energy technology with the intention of improving PTCA treatment results. Asahi Intecc said it will look for ways to incorporate the plasma energy technolog...
Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions Asahi Intecc Source Type: news

MRI and submaximal angioplasty cost  effective for stroke prevention
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - July 1, 2018 Category: Drugs & Pharmacology Source Type: news

Clotting Time in Transfemoral PCI Linked to Bleeding Risk
WEDNESDAY, June 27, 2018 -- Higher maximal activated clotting time (ACT) is associated with a greater risk of major bleeding after transfemoral (TF) percutaneous coronary intervention (PCI) than after transradial (TR) PCI, according to a study... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 27, 2018 Category: Pharmaceuticals Source Type: news

FDA OKs IN.PACT ™ Admiral™ Drug Coated Balloons of 200mm and 250mm Lengths
A subset of Medtronic's IN.PACT Global Study analyzed very long lesions in the SFA of over 180mm (7 inches), including cases of in-stent restenosis (ISR) and chronic total occlusions (CTO). The one-year results showed patency of 89.1% and clinically-driven target lesion revascularization at 7.1%. As a result of these findings, in April the FDA approved the IN.PACT DCB for treatment of long lesions. And last week, the FDA approved two new long length IN.PACT balloons (200mm and 250mm) that will become an important part of the armamentarium, implementing the April long lesion approval. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 23, 2018 Category: Cardiology 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

Corindus wins Japanese PMDA clearance for CorPath GRX platform
Corindus Vascular Robotics (OTC:CVRS) said today it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device. The CorPath GRX vascular robotics platform is designed to assist cardiologists in performing percutaneous coronary interventions, including angioplasty and stent placement, Corindus said. “I look forward to offering CorPath GRX to my patients during PCI, especially in complex procedures where precision and procedural control are extremely valuable. We are pleased to be one of the first Asia-Pacific countries to adopt this new and innovative tec...
Source: Mass Device - June 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Robotics Vascular Corindus Vascular Robotics Source Type: news

Consistent CTO: Trial Finds Benefit of PCI for Total Occlusion Consistent CTO: Trial Finds Benefit of PCI for Total Occlusion
Percutaneous coronary intervention opened 90% of complex chronic total occlusions and offered quality-of-life benefits to a contemporary cohort of highly symptomatic patients.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 4, 2018 Category: Consumer Health News Tags: Cardiology News 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

EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis
At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSXtouted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon. The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting stent or drug-coated balloon. Get the full story at our sister site, Drug Delivery Business News. The post EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Wall Street Beat Amaranth Medical B. Braun Boston Scientific Source Type: news

Many Prescriptions for Newer, More Expensive Antiplatelet Agents Go Unfilled Many Prescriptions for Newer, More Expensive Antiplatelet Agents Go Unfilled
Prescriptions for the P2Y12 inhibitors prasugrel hydrochloride and ticagrelor hydrochloride after percutaneous coronary intervention (PCI) are outpacing those for clopidogrel, but many patients are not filling those prescriptions, researchers report.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 22, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Reporting outcomes of PCI may not improve care
(Reuters Health) - Public reporting of outcomes for percutaneous coronary intervention (PCI) was supposed to improve quality, but some doctors say it hasn't delivered on the goal of enhancing patient care. (Source: Reuters: Health)
Source: Reuters: Health - May 17, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Teleflex launches TrapLiner cath in the EU
Teleflex (NYSE:TFX) said yesterday it launched the TrapLiner catheter, designed for use in vascular procedures, in Europe. The Wayne, Penn.-based company said that its TrapLiner cath is similar in design to its GuideLiner V3 cath but also features an integrated balloon for trapping standard 0.014″ guidewires within a guide catheter. The newly launched TrapLiner catheter is designed to operate as an alternative method to the trapping technique which requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position, Teleflex said. The catheter is intended for us...
Source: Mass Device - May 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters 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

Doctors May Avoid Performing PCI Due to Public Reporting
WEDNESDAY, May 16, 2018 -- Current percutaneous coronary intervention (PCI) public reporting programs could have negative effects, with physicians avoiding PCI in high-risk patients, according to a study published online May 9 in JAMA... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 16, 2018 Category: Pharmaceuticals 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

How do public 'report cards' affect physicians' treatment decisions?
(Beth Israel Deaconess Medical Center) Researchers from the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center (BIDMC) provide a closer look at physicians' knowledge, attitudes and beliefs about public reporting on percutaneous coronary intervention (PCI). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 10, 2018 Category: International Medicine & Public Health 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

Zoll Medical leads debt round for TherOx
TherOx said today it completed a new round of debt financing led by Asahi Kasei (TYO:3407) subsidiary Zoll Medical for an undisclosed amount. Funds from the deal will be used to support the US market introduction and commercialization of the Irvine, Calif.-based company’s SuperSaturated Oxygen Therapy system designed to treat patients with acute myocardial infarction once the system wins FDA premarket approval. TherOx said that it also recently released results from a study of its SSO2 Therapy system which confirmed the safety and effectiveness of the device in the treatment of anterior acute myocardia...
Source: Mass Device - May 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Asahi Kasei Corp. TherOx Inc Zoll Medical Corp. Source Type: news

Timely Receipt of PCI in STEMI Up With Hospital Bypass Policy
TUESDAY, May 1, 2018 -- Adoption of policies allowing emergency medical services (EMS) to bypass non-percutaneous coronary intervention (PCI) capable hospitals for patients with ST-segment elevation myocardial infarction (STEMI) is associated with... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 1, 2018 Category: Pharmaceuticals Source Type: news

SCAI updates consensus on length of stay for percutaneous coronary intervention
(Society for Cardiovascular Angiography and Interventions) Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary intervention (PCI) will allow for flexibility in length of stay while ensuring patient safety. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 25, 2018 Category: International Medicine & Public Health 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

Are angioplasty waiting time inequalities growing again?
This research looked at trends between 2002 and 2015 in waiting times for coronary angioplasty. Early indications suggest that socioeconomic inequality in waiting times for non-emergency coronary angioplasty within hospitals may have started rising in England since 2008. It also indicates that waiting times are 20% longer for patients living in deprived areas compared to patient from more affluent neighbourhoods. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 19, 2018 Category: Consumer Health News 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

Medical device company Intact Vascular raises $20M
The funds will support the company's development of an implant used in post-angioplasty dissections above the knee. Investors included Philadelphia-based Quaker Partners. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 16, 2018 Category: American Health Authors: John George 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

Heavy US Burden of 30-Day Readmissions After PCI Heavy US Burden of 30-Day Readmissions After PCI
Almost 1 in 10 Americans undergoing percutaneous coronary intervention return with an unplanned readmission within 30 days, despite advances in the technology.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 13, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Asahi Intecc to begin direct sales of PCTA guidewires
Asahi Intecc said today it plans to begin direct sales of its coronary percutaneous transluminal coronary angioplasty guidewires in the US, which are currently only distributed by Abbott‘s  (NYSE:ABT) vascular division. The shift will take place on July 1, at which time Asahi’s entire portfolio of PTCA guidewires will be available directly from it, the Tustin, Calif.-based company said. All sales requests before the shift will be directed through Abbott, the company said. Asahi said that in preparation for the direct offering, it has increased its sales, clinical, marketing and customer support teams. Repr...
Source: Mass Device - April 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Distribution Vascular Abbott Asahi Intecc Source Type: news

Abbot launches study comparing OCT to angiography in stent placement procedures
Abbott (NYSE:ABT) today announced the launch of new trial exploring long-term outcomes in patients who underwent stent implantation guided by optical coherence tomography as compared to angiography. The first patient in the trial was enrolled by Dr. Franco Fabbiocchi at Milan, Italy’s IRCCS Centro Cardiologico, the Abbot Park, Ill.-based company said. “Today, most of the world uses angiography for stent implantation using a two-dimensional view of the coronary artery to assess a complex three-dimensional structure. Physicians need new technology to help optimize percutaneous coronary intervention, and OCT ...
Source: Mass Device - April 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Imaging Abbott Source Type: news

Abbott launches study comparing OCT to angiography in stent placement procedures
Abbott (NYSE:ABT) today announced the launch of new trial exploring long-term outcomes in patients who underwent stent implantation guided by optical coherence tomography as compared to angiography. The first patient in the trial was enrolled by Dr. Franco Fabbiocchi at Milan, Italy’s IRCCS Centro Cardiologico, the Abbot Park, Ill.-based company said. “Today, most of the world uses angiography for stent implantation using a two-dimensional view of the coronary artery to assess a complex three-dimensional structure. Physicians need new technology to help optimize percutaneous coronary intervention, and OCT ...
Source: Mass Device - April 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Imaging Abbott Source Type: news

Better PCI Outcomes With Genotype-guided Antiplatelet Therapy Better PCI Outcomes With Genotype-guided Antiplatelet Therapy
The use of CYP2C19 genotype-guided antiplatelet therapy after percutaneous coronary intervention (PCI) is associated with better clinical outcomes, according to a new study.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 10, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Abiomed Earns FDA Approval for Adding Optical Sensor to Impella CP Heart Pump
Abiomed, which had a busy 2017 and was among our Company of the Year finalists, reported today that it has received FDA premarket approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. The sensor is one component of the SmartAssist technology, which also includes a software update enabling informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP), and cardiac power output (CPO) data on the Impella Console, an Abiomed spokesperson told MD+DI. The Impella CP heart pump had already earned FDA approval for treating patients in cardiogenic shock as well as patie...
Source: MDDI - April 2, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Cardiovascular Source Type: news

Foxtrot ™ NC PTCA Gains Regulatory Approval in Malaysia
(Source: Microport News Release)
Source: Microport News Release - March 29, 2018 Category: Medical Devices 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

FDA clears robotic movement software from Corindus
The FDA granted 510(k) clearance to the first automated robotic movement software designed for Corindus Vascular Robotics (OTC:CVRS) CorPath GRX percutaneous coronary intervention platform, the company reported today. The Rotate on Retract feature allows the person operating the CorPath GRX to navigate to a targeted lesion by automatically turning the guidewire upon joystick retraction. The software also won CE Mark approval in the European Union earlier this year. Today, Dr. Nelson Bernado, the medical director of MedStar Heart Institute’s Peripheral Vascular Laboratory, is slated to perform a robotic-assited p...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robotics Software / IT Vascular Corindus Vascular Robotics Source Type: news

ACC, Saudi Arabian Cardiac Interventional Society partner on registries
(American College of Cardiology) The American College of Cardiology and the Saudi Arabian Cardiac Interventional Society have partnered to implement the National Cardiovascular Data Registry's (NCDR) CathPCI Registry in hospitals across Saudi Arabia. The CathPCI Registry assesses the characteristics, treatments and outcomes of heart disease patients who receive diagnostic catheterization as well as percutaneous coronary intervention procedures. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 27, 2018 Category: International Medicine & Public Health Source Type: news

Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures. With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number of co-morbidities with or without depressed ejection fractions, the Danvers, Mass.-based company said. “This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned d...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news