How To Mend A Broken Heart
(Photo: © Kyle Bean) The need to mend broken hearts has never been greater. But what if we could simply manufacture a new one? Alex O’Brien studies the legacy of Texan surgeons and artificial hearts.Haskell Karp was 37 when he suffered his first heart attack, and over the next ten years he suffered a variety of related problems. By 1969 even the slightest effort, like combing his hair or brushing his teeth, would bring on chest pain or extreme shortness of breath. There are four grades of heart failure under the classification determined in 1928 by the New York Heart Association; Karp’s was classified a...
Source: Science - The Huffington Post - June 8, 2015 Category: Science Source Type: news

FDA Allows St. Jude To Resume Transcatheter Heart Valve Trial
St. Jude Medical has received approval from the FDA to resume the investigational device exemption (IDE) trial evaluating its Portico Transcatheter Aortic Valve Implantation System after internal and independent reviews of the previously halted study showed no adverse events associated with the implants. (Source: Medical Design Online News)
Source: Medical Design Online News - June 5, 2015 Category: Medical Equipment Source Type: news

MassDevice.com +3 | The top 3 medtech stories for June 4, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.   3. TAVI: St. Jude Medical can resume Portico trial St. Jude Medical, which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said. Back in Septe...
Source: Mass Device - June 4, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

TAVI: St. Jude Medical can resume Portico trial
St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said yesterday. Back in September 2014, St. Jude said CT scans turned up a potential problem with the Portico valves in […] The post TAVI: St. Jude Medical can resume Portico trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Source Type: news

Positive early data for Valtech’s Cardioband
A trial of Valtech Cardio‘s Cardioband transcatheter annuloplasty system showed no device-related mortality, with decreases in mitral regurgitation and septo-lateral dimension. Results from the 40-patient multicenter observational study, designed to evaluate the safety and performance of the Cardioband, were presented this week at the European Society of Cardiology’s annual meeting in Paris. The study was […] The post Positive early data for Valtech’s Cardioband appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Heart valves Valtech Cardio Source Type: news

New Hybrid Heart Valve Design Combines Metal, Engineered Tissue
Scientists at the University of California, Irvine (UCI) have developed a heart valve replacement made from a combination of metal and engineered tissue. Because the new hybrid valve is both patient-specific and durable, researchers believe it could overcome complications caused by existing valve replacement options. (Source: Medical Design Online News)
Source: Medical Design Online News - June 3, 2015 Category: Medical Equipment Source Type: news

NEIGRIHMS doctors successfully perform beating heart valve replacement
NEIGRIHMS boasts of having a cardiac surgery department which performs heart surgeries catering to all ages with varied heart ailments in the entire north east. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 3, 2015 Category: Pharmaceuticals Source Type: news

Where Medtronic makes its money after the Covidien acquisition
Medtronic has been about more than pacemakers for a long time, but that's more true than ever thanks to the company's acquisition of Covidien. The medical-device giant on Tuesday released its first earnings report that includes financial results from Covidien, and it also broke out how its revenue mix changed as a combined company. As a standalone business, Medtronic's cardiac and vascular business — a unit that includes bread-and-butter heart devices like defibrillators and heart valves —… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 2, 2015 Category: Biotechnology Authors: Katharine Grayson Source Type: news

Where Medtronic makes its money after the Covidien acquisition
Medtronic has been about more than pacemakers for a long time, but that's more true than ever thanks to the company's acquisition of Covidien. The medical-device giant on Tuesday released its first earnings report that includes financial results from Covidien, and it also broke out how its revenue mix changed as a combined company. As a standalone business, Medtronic's cardiac and vascular business — a unit that includes bread-and-butter heart devices like defibrillators and heart valves —… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - June 2, 2015 Category: Hospital Management Authors: Katharine Grayson Source Type: news

TAVI: Good early data for Keystone Heart’s TriGuard
Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris. The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to […] The post TAVI: Good early data for Keystone Heart’s TriGuard appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Neurological Replacement Heart Valves Keystone Heart TAVI Source Type: news

Neochord raises $12.6m for mitral repair device
Neochord said it raised $12.6 million in debt of a hoped-for $20 million funding round to support its DS1000 minimally invasive mitral valve repair system. The Neochord device is designed to allow the implantation of artificial chordae tendinae, thread-like connectors that anchor leaflets of the mitral valve to heart muscle, the Minnesota-based medical device company […] The post Neochord raises $12.6m for mitral repair device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 1, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Funding Roundup Heart valves Source Type: news

EuroPCR 2015: Edwards pauses Fortis TMVI, TAVI gains across the board
Replacement heart valves once again take center stage at the annual EuroPCR conference in Paris this week, as Edwards Lifesciences pauses its Fortis trial and positive new data comes in on the next generation of aortic implants. EuroPCRNews Well, Cardiovascular, EuroPCR 2015, Peripheral Artery Disease, Replacement Heart Valves, Stentsread more (Source: Mass Device)
Source: Mass Device - May 22, 2015 Category: Medical Equipment Authors: Fink Densford Source Type: news

John Glenn Says Evolution Should Be Taught In Schools
COLUMBUS, Ohio (AP) — John Glenn, who declared as a 77-year-old in a news conference from space that "to look out at this kind of creation out here and not believe in God is to me impossible," says facts about scientific discovery should be taught in schools — and that includes evolution. The astronaut, now 93 with fading eyesight and hearing, told The Associated Press in a recent interview that he sees no contradiction between believing in God and believing in evolution. "I don't see that I'm any less religious by the fact that I can appreciate the fact that science just records that we change...
Source: Science - The Huffington Post - May 20, 2015 Category: Science Source Type: news

Edwards stops small mitral heart valve study
(Reuters) - Edwards Lifesciences Corp on Tuesday said it stopped enrolling patients in a small study of its less-invasive mitral heart valve device due to the formation of blood clots associated with the procedure. (Source: Reuters: Health)
Source: Reuters: Health - May 19, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

TAVI: Study shows 80% survival at 2 years for Direct Flow device
Direct Flow Medical says 2-year data from its Discover CE Mark trial showed an 80% survival rate at 2 years for its transcatheter aortic valve implant. Direct Flow Medical today said data from a clinical trial of its replacement heart valve showed an 80% survival rate after 2 years. Direct Flow Medical Inc.News Well, Clinical Trials, Replacement Heart Valvesread more (Source: Mass Device)
Source: Mass Device - May 19, 2015 Category: Medical Equipment Authors: Fink Densford Source Type: news

Edwards Hits A Bump in the Road in Heart Valve Trial
(Source: MDDI)
Source: MDDI - May 19, 2015 Category: Medical Equipment Authors: Arundhati Parmar Tags: Implantable Devices Source Type: news

Biotronik looks to get into the TAVI game
Biotronik touts 1st-in-human data for its entry into the transcatheter aortic valve implant market, saying the device passed its 30-day safety endpoint. Biotronik today said its entry into a hot replacement heart valve market passed the safety endpoint of a 1st-in-human trial. The German medical device giant said the Biovalve trial of its transcatheter aortic valve implant established the device's early safety at 30 days. BiotronikNews Well, Clinical Trials, Replacement Heart Valves, TAVIread more (Source: Mass Device)
Source: Mass Device - May 12, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

South Africa: SA Doctors Develop Affordable Heart Valves
[SA Info] Cardiac surgery techniques and technology were driven, in the 1960s in Europe and America, by the high death toll from rheumatic heart disease (RHD). In the 1970s the global burden of disease changed and RHD all but disappeared in the global north - but it continues to kill hundreds of thousands in the developing world. A locally developed heart valve is set to change that. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - May 11, 2015 Category: African Health Source Type: news

TAVI: Edwards CEO says Sapien 3 could hit U.S. market this year
Edwards Lifesciences CEO Michael Mussallem says the company now expects the FDA to approve its next-generation Sapien 3 replacement heart valve this year. Edwards LifesciencesNews Well, MassDevice.com Earnings Roundup, 2015, Q1, Replacement Heart Valvesread more (Source: Mass Device)
Source: Mass Device - April 24, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

NIH funds WPI study aimed at engineering more natural and durable replacement heart valves
(Worcester Polytechnic Institute) With a $450,000, three-year award from the National Institutes of Health, a team at Worcester Polytechnic Institute led by Kristen Billiar, Ph.D., professor of biomedical engineering, will analyze how mechanical forces and cellular growth factors affect the growth and development of human heart valves to advance the long-term goal of developing a new class of tissue-engineered heart valves that are more natural and longer-lasting than current replacement valves. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 22, 2015 Category: Global & Universal Source Type: news

Slippery Slope: Fen-Phen Users Recall a 'Miracle' Turned Nightmare
(MedPage Today) -- Two women who used fen-phen talk about their heart valve problems. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - April 19, 2015 Category: Cardiology Source Type: news

Why OHSU's super Starr is heading to Paris
Dr. Albert Starr, who co-invented and implanted the world’s first successful artificial heart valve, will be off to Paris in June to pick up a prestigious and magnifique international prize. Starr, who is 88 years old, is the 2015 recipient of the Institut de France's Grand Prix Scientifique. Valued at $500,000 euros, the Grand Prix is one of the largest prizes for scientific accomplishments. Starr’s research not only led to development of the groundbreaking Starr-Edwards heart valve in 1960,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2015 Category: Biotechnology Authors: Elizabeth Hayes Source Type: news

Why OHSU's super Starr is heading to Paris
Dr. Albert Starr, who co-invented and implanted the world’s first successful artificial heart valve, will be off to Paris in June to pick up a prestigious and magnifique international prize. Starr, who is 88 years old, is the 2015 recipient of the Institut de France's Grand Prix Scientifique. Valued at $500,000 euros, the Grand Prix is one of the largest prizes for scientific accomplishments. Starr’s research not only led to development of the groundbreaking Starr-Edwards heart valve in 1960,… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - April 15, 2015 Category: Hospital Management Authors: Elizabeth Hayes Source Type: news

Medtronic CoreValve® System Receives FDA Approval for Transcatheter Valve-In-Valve Procedures
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the CoreValve® System for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. The CoreValve System is the first transcatheter heart valve approved in the U.S. for VIV procedures in both high and extreme risk patients who have limited options or may otherwise go untreated. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 11, 2015 Category: Cardiology Source Type: news

From Geek to Chic: Our Nation's Most Innovative Makers
If I were to ask you if you are a maker, what would your response be? I recently saw a commercial that used this term to seemingly appeal to people's sense of identity. As a designer of children's science and creativity-based programs, maker is a popular buzzword in my world, but I find it exciting to know that it has seeped its way into common vernacular. From self-esteem boosting to problem-solving skill building, making is a natural part of a child's (and willing adult's) development. Makers can be thought of as the do-it-yourself-types who value the power of activities such as designing, prototyping, fabricating, cod...
Source: Science - The Huffington Post - April 9, 2015 Category: Science Source Type: news

TAVI: Direct Flow to put its valve up against Medtronic's CoreValve
The FDA says Direct Flow Medical can compare its transcatheter aortic valve implant with Medtronic's CoreValve in a clinical trial that's now slated to include a high-risk cohort. Direct Flow Medical Inc., Food & Drug Administration (FDA), MedtronicNews Well, Clinical Trials, Replacement Heart Valves, TAVIread more (Source: Mass Device)
Source: Mass Device - April 9, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

On-X Life Technologies wins expanded labeling indication from FDA | Regulatory news for the week of April 6, 2015
Here's a look at some of the top regulatory stories for medical device companies this week: FDA expands indication for On-X Life's heart valve; More CT scanner problems for Philips Healthcare; Augmenix wins FDA nod for SpaceOar prostate treatment; Biotronik launches Pantera Pro balloon catheter in Europe; Baxter wins CE Mark for home dialysis device FDA expands indication for On-X Life's heart valve April 3, 2015 by Mark Hollmer Augmenix Inc., Baxter International, Biotronik, Food & Drug Administration (FDA), On-X Life Technologies, Royal PhilipsNews Well, Regulatory/Complianceread more (Source: Mass Device)
Source: Mass Device - April 7, 2015 Category: Medical Equipment Authors: MassDevice Source Type: news

FDA Approval: On-X Aortic Valves With Less Warfarin
Thousands of Americans with On-X Aortic Heart Valves may be able to reduce their regular blood-thinning medication regimen, thanks to an expanded labeling claim just granted by the U.S. Food and Drug Administration (FDA) to On-X Life Technologies Inc. (ON-X LTI), the company announced recently. (Source: Medical Design Online News)
Source: Medical Design Online News - April 6, 2015 Category: Medical Equipment Source Type: news

FDA expands indication for On-X Life's heart valve
On-X Life Technologies wins an expanded labeling indication from the FDA for its replacement heart valve. On-X Life Technologies said it nailed down an expanded labeling claim from the FDA for its aortic mechanical heart valve. Food & Drug Administration (FDA), On-X Life TechnologiesNews Well, Regulatory/Compliance, Replacement Heart Valvesread more (Source: Mass Device)
Source: Mass Device - April 3, 2015 Category: Medical Equipment Authors: Mark Hollmer Source Type: news

Medtronic CoreValve System Receives FDA Approval For Transcatheter Valve-In-Valve Procedures
Medtronic plc recently announced the U.S. Food and Drug Administration (FDA) approval of the CoreValve System for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. (Source: Medical Design Online News)
Source: Medical Design Online News - April 1, 2015 Category: Medical Equipment Source Type: news

TAVI: Japan approves Medtronic's CoreValve
Regulators in Japan approve Medtronic's CoreValve transcatheter aortic valve implant. Medtronic (NYSE:MDT) today said it won approval in Japan for its CoreValve replacement heart valve. MedtronicNews Well, Exports, Regulatory/Compliance, Replacement Heart Valvesread more (Source: Mass Device)
Source: Mass Device - March 30, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

Heart valve repair improves emotional wellbeing in patients with mitral regurgitation
(Elsevier) Patients with severe mitral regurgitation often suffer from psycho-emotional symptoms, such as depression and anxiety, but after undergoing mitral valve repair surgery patients experience a marked improvement in emotional and physical wellbeing, according to an article in the March 2015 issue of The Annals of Thoracic Surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 17, 2015 Category: Global & Universal Source Type: news

ACC 2015: Danish study finds TAVI safe for low-risk patients
A Danish study presented at the American College of Cardiology's annual conference shows that transcatheter aortic valve implants are safe in low-risk patients. (Reuters) — Transcatheter aortic valve implantation is safe for low-risk patients, according to a study presented at the American College of Cardiology meeting in San Diego. American College of Cardiology, Edwards Lifesciences, MedtronicNews Well, Clinical Trials, Replacement Heart Valves, TAVIread more (Source: Mass Device)
Source: Mass Device - March 16, 2015 Category: Medical Equipment Authors: MassDevice Source Type: news

Implanted heart valve safe for low-risk patients: Danish study
(Reuters) - A minimally invasive procedure that allows doctors to implant a new heart valve supplying blood to the body is safe for low-risk patients, according to a study presented at the American College of Cardiology meeting in San Diego. (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Ablation during mitral valve surgery reduces atrial fibrillation
Patients with atrial fibrillation who received ablation while they were already undergoing surgery to correct a leaky heart valve had fewer episodes of atrial fibrillation a year later compared to patients who had the valve surgery alone, according to a new study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 16, 2015 Category: Science Source Type: news

SAPIEN valve, surgery equivalent at five years
Five-year data suggest that the SAPIEN transcatheter heart valve is a feasible option for patients with severe aortic stenosis deemed to be at high risk for open-heart surgery, though valve leakage was more common with the first-generation valve evaluated in this study than with surgery, according to new research. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 16, 2015 Category: Science Source Type: news

SAPIEN 3 improves 30-day outcomes for major endpoints, study suggests
The SAPIEN 3 heart valve demonstrated lower death, stroke and paravalvular leak rates than earlier generation devices in patients at high risk for surgery and showed encouraging results in intermediate-risk patients, according to new research. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 16, 2015 Category: Science Source Type: news

TAVI: Strong results for heart valves from Edwards Lifesciences, Medtronic
Replacement heart valves made by Edwards Lifesciences and Medtronic once again dominate the American College of Cardiology's annual meeting, with long-term results for Edwards' Sapien and Medtronic's CoreValve complemented by even better data from their next-generation transcatheter aortic valve implants. Transcatheter aortic valve implants once again took the spotlight at the annual meeting of the American College of Cardiology, with a spate of studies both confirming the long-term benefits of the replacement heart valves and showing that newer TAVI versions are even better. American College of Cardiology, Edw...
Source: Mass Device - March 16, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

Ablation during mitral valve surgery reduces atrial fibrillation
(American College of Cardiology) Patients with atrial fibrillation who received ablation while they were already undergoing surgery to correct a leaky heart valve had fewer episodes of atrial fibrillation a year later compared to patients who had the valve surgery alone, according to a study presented at the American College of Cardiology's 64th Annual Scientific Session. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 16, 2015 Category: Global & Universal Source Type: news

Encouraging Long Term Results For Less Invasive Heart Valves
The publications five years ago of the two part PARTNER trial brought a major change in the treatment options available to some people with aortic valve disease, which is often an extremely serious condition with a poor prognosis. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who were not surgical candidates and then for patients who were at high risk for surgery. One important lingering concern about TAVR was whether its results would prove to be sufficiently durable. Now the final 5 year findings from the trial, published in two papers...
Source: Forbes.com Healthcare News - March 15, 2015 Category: Pharmaceuticals Authors: Larry Husten Source Type: news

Low mortality, stroke seen with newest Edwards TAVR system: study
(Reuters) - Researchers on Sunday presented trial data showing very low mortality and stroke rates using the third generation version of Edwards Lifesciences Corp's non-invasive heart valve replacement system that could help support its U.S. approval. (Source: Reuters: Health)
Source: Reuters: Health - March 15, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Medtronic valve replacement tops surgery after two years: study
(Reuters) - Patients treated with Medtronic Plc's CoreValve non-invasive heart valve replacement system fared better two years after the procedure than those who underwent surgical valve replacement, according to data from a study presented on Sunday. (Source: Reuters: Health)
Source: Reuters: Health - March 15, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Yale leads test of new device that protects the brain during heart-valve procedure
(Yale University) In the first multicenter trial of its kind, Yale researchers tested a new device that lowers the risk of stroke and cognitive decline in patients undergoing heart-valve replacement. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 15, 2015 Category: Global & Universal Source Type: news

St Jude Medical to Resume Portico Heart Valve Implants
(Source: MDDI)
Source: MDDI - March 12, 2015 Category: Medical Equipment Authors: Arundhati Parmar Tags: Cardiovascular Source Type: news

St. Jude Medical pushes 'play' on Portico TAVI device
St. Jude Medical can resume implantations of its Portico replacement heart valve after European authorities reinstated its CE Mark, the company tells MassDevice.com. St. Jude MedicalNews Well, Clinical Trials, CE Mark, Regulatory/Compliance, Replacement Heart Valvesread more (Source: Mass Device)
Source: Mass Device - March 12, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

Outcomes Vary With Minimally Invasive Heart Valve Replacement
Title: Outcomes Vary With Minimally Invasive Heart Valve ReplacementCategory: Health NewsCreated: 3/10/2015 12:00:00 AMLast Editorial Review: 3/11/2015 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - March 11, 2015 Category: Cardiology Source Type: news

Outcomes Vary with Minimally Invasive Heart Valve Replacement
Transcatheter procedure was designed for patients too frail for open heart surgery Source: HealthDay Related MedlinePlus Pages: Heart Surgery, Heart Valve Diseases (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - March 10, 2015 Category: Consumer Health News Source Type: news

High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic
(Updated with a clarification) (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - March 10, 2015 Category: Pharmaceuticals Authors: Larry Husten Source Type: news

Heart Valve Repair Surgery May Ease Mental Health Symptoms, Too
Researchers find procedure leads to reduced depression and anxiety (Source: WebMD Health)
Source: WebMD Health - March 2, 2015 Category: Consumer Health News Source Type: news

Heart Valve Repair Surgery May Ease Mental Health Symptoms, Too
Researchers find procedure leads to reduced depression and anxiety Source: HealthDay Related MedlinePlus Pages: Heart Valve Diseases, Mental Health (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - March 2, 2015 Category: Consumer Health News Source Type: news