Concordia researchers develop new method to evaluate artificial heart valves
(Concordia University) Using high-tech equipment to look at the flow downstream of a bi-leaflet mechanical heart valve, researchers at Concordia have devised a technique to detect obstructions in a type of mechanical heart valve they believe will contribute to safer follow-up methods for cardiologists and their patients. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 19, 2019 Category: International Medicine & Public Health Source Type: news

NIH-developed technique prevents obstruction in heart valve replacement
BASILICA procedure shows successful results for some high-risk patients. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - June 12, 2019 Category: American Health Source Type: news

Technique lowers risk of complications in heart valve replacement
Researchers devised a technique to avoid a fatal complication during a procedure to replace the heart ’s mitral valve. (Source: NIH Research Matters from the National Institutes of Health (NIH))
Source: NIH Research Matters from the National Institutes of Health (NIH) - June 11, 2019 Category: Consumer Health News Source Type: news

South Africa: Italian Surgeons Find World's Oldest Artificial Heart Valve Implanted By Chris Barnard 50 Years Ago
[News24Wire] Surgeons in Italy have made a rare discovery while operating on a 60-year-old woman - an artificial mitral valve that is almost 50 years old, and still working perfectly. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - May 27, 2019 Category: African Health Source Type: news

Defects in heart valve cilia during fetal development cause mitral valve prolapse
(Medical University of South Carolina) Genetic mutations in heart valve cells of the developing fetus lead to mitral valve prolapse, report a global collaborative of researchers, including Medical University of South Carolina investigators, in today's Science Translational Medicine. These mutations or genetic variations cause defects in antenna-like cellular structures called primary cilia. This finding of a developmental cause for the disease highlights the importance of early intervention and may lead to the rethinking of treatment guidelines. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - May 22, 2019 Category: Biology Source Type: news

TRILUMINATE Study Shows Treatment with Abbott's First-of-its-Kind Minimally Invasive Device Reduces Tricuspid Heart Valve Leaks
- Late-breaking data for Abbott's investigational clip-based tricuspid heart valve repair system presented at EuroPCR (Source: Abbott.com)
Source: Abbott.com - May 21, 2019 Category: Pharmaceuticals Source Type: news

Novel technique reduces obstruction risk in heart valve replacement
The transcatheter approach increases treatment options for high-risk patients. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - May 20, 2019 Category: American Health Source Type: news

Edwards Continues to Innovate in Surgical Valve Space
This study, a prospective, single-arm observational clinical trial of 133 patients conducted at two clinical sites in Europe, also yielded positive results. There were no events of SVD throughout the study period, Edwards noted. The company also plans to further evaluate the new tissue platform through the RESILIENCE trial, a longer-term study that will follow 250 patients under the age of 65. That study will examine calcification levels, hemodynamic deterioration, and valve failure at years five, seven, nine and 11 as early potential predictors of valve durability. (Source: MDDI)
Source: MDDI - May 13, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

The first-ever self-driving robot surgeon can navigate itself through the body
A new invention from Boston Children's Hospital successfully drove itself to the heart valves of pigs that needed to be fixed, moving just as quickly and accurately as human surgeons, study reveals. (Source: the Mail online | Health)
Source: the Mail online | Health - April 24, 2019 Category: Consumer Health News Source Type: news

Aortic Valve Disease Does Its Damage Slowly
SATURDAY, April 20, 2019 -- Aortic valve stenosis is a form of heart valve disease that can take many years to develop into a life-threatening problem, an expert says. It occurs when narrowing of the aortic valve opening prevents blood from the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 20, 2019 Category: General Medicine Source Type: news

3D goggles may soon help surgeons see better
(Reuters Health) - In a first, heart surgeons in Poland used 3D goggles to help them see inside a patient's chest as they opened up a narrowed heart valve, according to a report in the European Heart Journal. (Source: Reuters: Health)
Source: Reuters: Health - April 17, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

3D-bioprinted model mimics real human heart properties
Researchers from Israel have created a 3D-printed model that captures the immunological,...Read more on AuntMinnie.comRelated Reading: 3D printing reduces liver transplant costs, surgery time 3D printing helps separate rare case of conjoined twins 3D printing technique improves heart valve sizing 3D-printed aortas could work well for TAVR Flexible 3D-printed heart replicates size, texture (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 16, 2019 Category: Radiology Source Type: news

TAVR Puts the Swagger Back in Mick Jagger
Rolling Stones frontman Mick Jagger’s recent surgery is putting a huge spotlight on the transcatheter aortic valve replacement (TAVR) market. Late last week, Jagger tweeted that his procedure was a success and thanked fans for their support.   Thank you everyone for all your messages of support, I’m feeling much better now and on the mend - and also a huge thank you to all the hospital staff for doing a superb job. — Mick Jagger (@MickJagger) April 5, 2019 Problems for the 75-year-old began late last month after the rocker fell ill. As a result, the Rolling...
Source: MDDI - April 10, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

LivaNova shares plummet on prelim Q1 miss
LivaNova (NSDQ:LIVN) shares have plunged over 25% so far today after the medical device maker posted preliminary sales numbers for its first quarter that fell below expectations on Wall Street. The London-based company said that it expects to post sales of $250.5 million for the quarter, well below the Wall Street expectations of $264.6 million. The company reported preliminary sales of $121.5 million for its cardiopulmonary division, a drop of 2.9% compared with the same period during the previous year. Its heart valve business saw a larger drop, reporting preliminary sales of $25.6, down 17.5% from Q1 2018. LivaNova...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat LivaNova Source Type: news

Mick Jagger Recovering After Heart Surgery
Jagger had a procedure called transcatheter aortic valve replacement. Doctors accessed his heart valve using a catheter that was inserted through his femoral artery, avoiding the need to open Jagger's chest. (Source: WebMD Health)
Source: WebMD Health - April 5, 2019 Category: Consumer Health News Source Type: news

Edwards Lifesciences doubles down on Irish plant
Edwards Lifesciences (NYSE:EW)  reportedly plans to double its investment in a plant it’s building in Ireland that’s expected to add 600 jobs to the local economy. Last year the Irvine, Calif.-based company said it planned to build a new, 170,000-square-foot facility in Limerick to manufacture delivery components for its transcatheter heart valves. At the time the project was slated to cost about $93.3 million (EU €80 million) and open in 2021. Today Edwards said it will add another $93.3 million to the tab as it plans to build a larger plant but held to the 2021 timetable as it broke ground on t...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Replacement Heart Valves Edwards Lifesciences Source Type: news

Mick Jagger in Recovery After Heart Valve Procedure
FRIDAY, April 5, 2019 -- Giving millions of fans some " Satisfaction, " Rolling Stones frontman Mick Jagger is recovering and in good health after undergoing a heart valve procedure in New York City on Thursday. Jagger is being monitored for any... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 5, 2019 Category: General Medicine Source Type: news

Health Highlights: April 5, 2019
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Mick Jagger Recovering After Heart Valve Procedure Mick Jagger is recovering and in good health after his heart valve procedure. The Rolling... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 5, 2019 Category: General Medicine Source Type: news

Mick Jagger Recovering After Heart Valve Procedure
Title: Mick Jagger Recovering After Heart Valve ProcedureCategory: Health NewsCreated: 4/4/2019 12:00:00 AMLast Editorial Review: 4/5/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - April 5, 2019 Category: Cardiology Source Type: news

Tioga Medical raises $15m to support transcath mitral, tricuspid valve tech
Newly formed Shifamed portfolio company Tioga Medical said today that it closed a $15 million Series A preferred stock financing round to support its transcatheter mitral and tricuspid valve replacement technology. The Campbell, Calif.-based company said that it is developing novel transcatheter valve replacement technology intended to be simpler and less invasive than current mitral and tricuspid valve replacement approaches. Tioga Medical will initially focus on technology for mitral valve replacement, stating that there is a “significant clinical need for less invasive, transcatheter approaches for mitral val...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters Replacement Heart Valves tiogamedical Source Type: news

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world ’ s smallest heart valve for newborns.pic.twitter.com/SNokx8QVXW
Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart valve for newborns. pic.twitter.com/SNokx8QVXW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 4, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

AHA News: Surgery Like Jagger: Doctors Explain Heart Valve Problems, Treatment
WEDNESDAY, April 3, 2019 (American Heart Association News) -- Rolling Stones fans were concerned by the news Mick Jagger needs a new heart valve. But they'll be happy to know that these days most patients in his situation can get what they need --... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 4, 2019 Category: General Medicine Source Type: news

AHA News: Surgery Like Jagger: Doctors Explain Heart Valve Problems, Treatment
Title: AHA News: Surgery Like Jagger: Doctors Explain Heart Valve Problems, TreatmentCategory: Health NewsCreated: 4/4/2019 12:00:00 AMLast Editorial Review: 4/4/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - April 4, 2019 Category: Cardiology Source Type: news

Mick Jagger to Have Heart Valve Surgery
Title: Mick Jagger to Have Heart Valve SurgeryCategory: Health NewsCreated: 4/2/2019 12:00:00 AMLast Editorial Review: 4/3/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - April 3, 2019 Category: Cardiology Source Type: news

Mick Jagger's having his heart valve replaced. The technology is better than ever
Rolling Stones frontman Mick Jagger is having a heart valve replaced this week, a source close to the band tells CNN. (Source: CNN.com - Health)
Source: CNN.com - Health - April 3, 2019 Category: Consumer Health News Source Type: news

Mick Jagger Facing Heart Surgery
Heart-valve replacement surgery typically comes with a recover of anywhere from a week to 4-to-6 weeks for open-heart surgery. (Source: WebMD Health)
Source: WebMD Health - April 2, 2019 Category: Consumer Health News Source Type: news

CMS touts ‘ more flexibility ’ in new TAVR coverage requirements
The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs. The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still new. The new policy from CMS looks to update requirements based on new information about the safety and viability of the procedures. The new proposal, released yesterday, would reduce the number of cardiac surgeons required to independently examine...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Source Type: news

Transcatheter Heart Valve Interventions: Where Are We? Transcatheter Heart Valve Interventions: Where Are We?
While percutaneous approaches have transformed management of valvular heart disease, more knowledge is needed to ensure optimal patient outcomes.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 27, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Top presentations at #AGS19 address prescription patterns, hypertension, frailty
(American Geriatrics Society) Data on the chronic use of opioids following spinal surgery, intensified treatment of high blood pressure after hospital discharge, and assessments of which frailty measures best predict poor outcomes following aortic heart valve replacement are among headline presentations at the American Geriatrics Society (AGS) 2019 Annual Scientific Meeting (#AGS19), held May 2-4 in Portland, Ore. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - March 27, 2019 Category: International Medicine & Public Health Source Type: news

Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve
Neovasc (NSDQ:NVCN) today claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there. In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today. Munich’s Higher Re...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Replacement Heart Valves Wall Street Beat CardiAQ Valve Technologies Edwards Lifesciences neovasc Source Type: news

Echocardiography identifies patients for valve repair
Echocardiography can help determine which patients with heart failure and leaking...Read more on AuntMinnie.comRelated Reading: Lung ultrasound beats chest x-ray for heart failure detection Societies renew call to pull ultrasound contrast warning ACC, ASE release echocardiography training guidance ASE offers TEE guidelines for congenital heart disease Heart valve-tracking algorithm boosts viability of 4D MRI (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 19, 2019 Category: Radiology Source Type: news

ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients. Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said. The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device. Abiomed said that it met wi...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Patient Monitoring Replacement Heart Valves Abbott Abiomed Medtronic Source Type: news

Expandable Heart Valves Could Mean Fewer Surgeries
Expandable aortic valves are guided to the heart through a catheter into a blood vessel and placed inside the old valve. (Source: WebMD Health)
Source: WebMD Health - March 18, 2019 Category: Consumer Health News Source Type: news

ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at ...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

Health Highlights: March 18, 2019
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Expandable Heart Valves Could Mean Fewer Surgeries Expandable heart valves that can be placed in the heart through a minimally invasive... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 18, 2019 Category: General Medicine Source Type: news

Expandable Heart Valves Could Mean Fewer Heart Surgeries
Title: Expandable Heart Valves Could Mean Fewer Heart SurgeriesCategory: Health NewsCreated: 3/18/2019 12:00:00 AMLast Editorial Review: 3/18/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - March 18, 2019 Category: Cardiology Source Type: news

Edwards, Medtronic heart valve systems prove worth in low-risk patients -studies
Non-invasive heart valve replacement systems from Medtronic Plc and rival Edwards Lifesciences Corp proved as good or better than open heart surgery in younger, more active patients for whom the surgical option was deemed low risk, according to trial results that had been scheduled to be presented on Sunday. (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Edwards, Medtronic heart valve systems prove worth in low-risk patients: studies
Non-invasive heart valve replacement systems from Medtronic Plc and rival Edwards Lifesciences Corp proved as good or better than open heart surgery in younger, more active patients for whom the surgical option was deemed low risk, according to trial results presented on Saturday. (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

In study, TAVR is superior to surgery for low-risk patients with aortic valve stenosis
(Columbia University Irving Medical Center) A large clinical trial has found that a minimally invasive procedure to replace a narrowed heart valve performed better than surgery in patients who were good candidates for surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 16, 2019 Category: International Medicine & Public Health Source Type: news

FDA ramps up scrutiny of materials in medical devices
(Image by Michael Longmire on Unsplash) The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ &ld...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Cardiovascular Featured Food & Drug Administration (FDA) Implants Materials Testing Metal-on-Metal News Well Oncology Orthopedics Regulatory/Compliance Replacement Heart Valves Stents Surgical Women's Health ani Source Type: news

FDA Wants to Take a Hard Look at Medical Device Materials
As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.  The agency released a statement Friday from Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health that addresses recent advances in materials science and how these advances have impacted the safety of medical devices. "Materials used in today's medical devices vary as widely as the devices themselves—whether the material is metal, plastic, silicone, an animal-derived product or some combination of these," Got...
Source: MDDI - March 15, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Materials Regulatory and Compliance Source Type: news

FDA Approves New Indication for Valve Repair Device to Treat Certain Heart Failure Patients with Mitral Regurgitation
SILVER SPRING, Md., March 14, 2019 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitat... Devices, Interventional, Cardiology, FDA Abbott Vascular, MitraClip, mitral valve, mitral regurgitation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 14, 2019 Category: Pharmaceuticals Source Type: news

Neovasc advances warrant exchange from CardiAQ case
Neovasc (NSDQ:NVCN) said today that it inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the damages from litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. The Vancouver-based replacement heart valve developer said it plans to exchange the Series A and Series E warrants it issued in November 2017 to cover the $42 million balance from its loss in the CardiAQ lawsuit. The deals call for Neovasc to issue more than 496,000 shares in exchange for nearly 58.4 million warrants, which works out to 0.0085 shares per warrant. “We ...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Legal News Replacement Heart Valves Wall Street Beat neovasc Source Type: news

Edwards Makes Significant Moves in the Mitral Valve Space
Edwards Lifesciences bolstered its presence in the mitral valve space through a pair of transactions it announced Monday. The Irvine, CA based company invested $35 million in an exclusive right to acquire Corvia Medical and in addition the firm obtained certain assets of Mitralign for an undisclosed sum. Edwards investments come on the heels of Boston Scientific exercising its option to acquire the remaining shares of Millipede Inc. for $325 million. In addition, the Marlborough, MA-based company said a $125 million payment becoming available upon achievement of a commercial milestone. Tewksbury, MA-based Corvia Medical&ac...
Source: MDDI - March 11, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Edwards Lifesciences gets in on Corvia, Mitralign
Edwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets. Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said. &ldquo...
Source: Mass Device - March 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Mergers & Acquisitions Replacement Heart Valves Edwards Lifesciences Source Type: news

FDA Slammed for & #039;Hiding & #039; Device-Related Injury Reports
An investigative report claims FDA is hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program. Kaiser Health News reported that at least 1.1 million incidents have been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE. The Kaiser report focuses on the obscurity of the practice, which was created nearly 22 years ago, as MD+DI reported at the time. Back in 1997, FDA urged manufacturers of 12 types of medical devices to request permission to submit only summary ...
Source: MDDI - March 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Report: FDA hiding millions of adverse event reports from docs, public
The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News. Since 2016, at least 1.1 million such reports have been ingested into the FDA’s “alternative summary reporting” repository, a system inaccessible to the public and so obscure that former agency head Dr. Robert Califf said he’d “never heard anything about it,” according to the report. The summary reporting repository was originally created as an alternative for issues “well-known and well-documented with the FDA” and covers appr...
Source: Mass Device - March 7, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

A New Way of Looking at Things
It can get pretty crowded in an interventional procedure room, specifically for those places where image-guided therapy is being conducted. “Some of these procedures may require upwards of 15—or sometimes even 20—people in the suite,” said Barry T. Katzen, MD, founder and chief medical executive of Miami Cardiac & Vascular Institute, part of Baptist Health South Florida, in an interview with MD+DI. “And all of them have certain needs for technology, for space, for visualization, and things like that.” He noted th...
Source: MDDI - March 4, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Imaging Source Type: news

New joint Position Statement published on safe treatment of hyperprolactinaemia
The paper,“Echocardiography and monitoring patients receiving dopamine agonist therapy for hyperprolactinaemia: A joint position statement of the British Society of Echocardiography, the British Heart Valve Society and the Society for Endocrinology” was published today in bothClinical Endocrinology andEcho Research and Practice.This joint statement, written collaboratively by the key Societies with an interest in this condition, is important reading for any general medical professionals, as well as those in the cardiovascular and endocrine fields, that are involved in managing patients with hyperprolact...
Source: Society for Endocrinology - March 1, 2019 Category: Endocrinology Source Type: news

Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between Se...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news