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

Cardiovascular Systems enters Chinese market through OrbusNeich deal
Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich. St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong. “Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap o...
Source: Mass Device - November 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Distribution Cardiovascular Systems Inc. OrbusNeich 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

What & #039;s Next for Bioresorbable Scaffolds?
Even with new data, the future of bioresorbable scaffolds remains in flux. At TCT 2018 in September, Reva Medical and Abbott Laboratories painted differing pictures with their respective bioresorbable scaffold studies. What now? Dr. Lukasz Koltowski from the Medical University of Warsaw in Warsaw, Poland, presented new data from Reva Medical's "Fantom STEMI" pilot study. The study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in nine patients with acute ST-segment elevated myocardial infarction (“STEMI”) heart attacks. "Many heart atta...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: Business Cardiovascular 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 2, 2018 Category: Cardiology Source Type: news

Common Diabetes Meds May Raise Odds for Amputation
For people with type 2 diabetes, taking a diuretic raised the odds of having an amputation, or requiring an angioplasty or bypass, by 75 percent or more, compared with those not using the medicines, researchers said this week. (Source: WebMD Health)
Source: WebMD Health - October 2, 2018 Category: Consumer Health News 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

FDA clears 1st acute coronary artery perforation stent in 17 years
The FDA said today it approved Biotronik’s PK Papyrus covered coronary stent system intended to treat acute coronary artery perforations, touting it as the first such device to win clearance for that indication in 17 years. Coronary artery perforations can occur during percutaneous coronary intervention procedures and can create life-threatening conditions, the FDA said. In some such perforations, blood can leak through the tear and lead to a collection of blood in the sac surrounding the heart, putting a patient’s life at serious risk. The newly cleared PK Papyrus is a balloon-expandable covered coronary stent...
Source: Mass Device - September 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Stents Biotronik Source Type: news

FDA Approves First New Device for Heart Vessel Tears in 17 Years
  Cardiologists have a new tool for handling a rare but potentially life-threatening complication during percutaneous coronary intervention (PCI) procedures. FDA approved Biotronik's PK Papyrus Covered Coronary Stent System as a treatment for tears in the coronary arteries that can occur during heart vessel procedures. The PK Papyrus System is the first device FDA has approved for this indication in 17 years. The device has been CE marked for sale in Europe since 2013. "The PK Papyrus Covered Coronary Stent System provides healthcare providers with a new treatment option...
Source: MDDI - September 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Acute myocardial infarction secondary to blunt chest trauma in motorcycle accident: a rare combination where percutaneous coronary intervention and intravascular imaging optimization are needed - Boi A, Sanna F, Rossi A, Loi B.
Blunt chest trauma is a common occurrence in vehicle accident. Cardiac injuries following nonpenetrating thoracic trauma have been reported. ST-elevation myocardial infarction (STEMI) due to coronary artery involvement is a rare but extremely serious condi... (Source: SafetyLit)
Source: SafetyLit - September 14, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Women are a FIFTH more likely to die after routine surgery for coronary heart disease
EXCLUSIVE Researchers from Keele University analysed 6.6 million patients over 10 years and found women who have a percutaneous coronary intervention are more at risk than men. (Source: the Mail online | Health)
Source: the Mail online | Health - September 10, 2018 Category: Consumer Health News Source Type: news

Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent thrombosis following DAPT interruption or discontinuation after one month with a next-gen drug-eluting stent, according to Medtronic. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic launches one-month DAPT study for dr...
Source: Mass Device - September 10, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Wall Street Beat Medtronic Source Type: news

Intravascular ultrasound-guided percutaneous coronary intervention: An updated review
(Cardiovascular Innovations and Applications) In the current issue of Cardiovascular Innovations and Applications (Volume3, Number 2, 2018, pp. 127-136(10); DOI, Dhruv Mahtta, Ahmed N. Mahmoud, Mohammad K. Mojadidi and Islam Y. Elgendy from the University of Florida, Gainesville, Fla., USA consider intravascular ultrasound-guided percutaneous coronary intervention. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 10, 2018 Category: International Medicine & Public Health 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

MicroPort < sup > ® < /sup > Firefighter ™ PTCA Balloon Catheter Obtains Approval for Registration in Mexico
(Source: Microport News Release)
Source: Microport News Release - August 15, 2018 Category: Medical Devices Source Type: news

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