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Danny ’s journey to a biventricular heart
The first hint that something wasn’t quite right with Danny Sanchez-Garcia’s heart came at his mom’s six-month prenatal visit. “There was a little blip on the ultrasound, but then it was gone on the next one, so they didn’t think it was anything and I didn’t worry any more about it,” says Danny’s mom, Cynthia. Cynthia was overjoyed when Danny was born at her local hospital seeming perfectly healthy. But as the hospital staff monitored Danny overnight, they noticed his oxygen level was lower than normal and decided to run more tests. His doctors believed the tests pointed to a...
Source: Thrive, Children's Hospital Boston - November 15, 2017 Category: Pediatrics Authors: Ellen Greenlaw Tags: Diseases & Conditions Our Patients’ Stories Biventricular Repair Complex Biventricular Repair Program congenital heart valve program double outlet right ventricle Dr. Christopher Baird Dr. Roger Breitbart ECMO Pulmonary atresia tetra Source Type: news

Xeltis raises $53m Series C round for replacement heart valve programs
Xeltis said today that it closed a Series C round worth more than $53 million (€45 million) for the bioresorbable heart valve technology it’s developing. The Eindhoven, Holland- and Zurich-based company said the round was led by “a global strategic investor,” joined by Ysios Capital, “a number of large private investors,” prior backers LSP, Kurma Partners and VI Partners and other previously involved private investors. Xeltis said it plans to use the cash to back the clinical programs for its aortic and pulmonary valves, built on endogenous tissue restoration technology. That&rs...
Source: Mass Device - November 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Regenerative Medicine Replacement Heart Valves Wall Street Beat Xeltis Source Type: news

Xeltis Closes €45 Million in Oversubscribed Series C Financing to Advance Aortic and Pulmonary Valve Programs
The largest investment round for a private medical device company in Europe in 2017 EINDHOVEN, The Netherlands and ZURICH, November 15, 2017 -- (Healthcare Sales & Marketing Network) -- Xeltis, a clinical-stage medical device company pioneering a resto... Devices, Cardioloy, Venture Capital Xeltis , Endogenous Tissue Restoration, heart valve therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 15, 2017 Category: Pharmaceuticals Source Type: news

Neovasc looks to raise $65m to cover trade secret ruling, trials
Neovasc (NSDQ:NVCN) said last week that it’s looking to raise more than $65 million in a stock offering and a private placement as it seeks to come up with a $42 million shortfall stemming from its trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal jud...
Source: Mass Device - November 13, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Neovasc Inc. Source Type: news

Medtronic shares up on Q2 prelims, limited Hurricane impact
Medtronic (NYSE:MDT) yesterday released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share. The Fridley, Minn.-based company said it expects to post sales of $7.05 billion, which is down 4% from the same quarter the prior year but still ahead of the $6.87 billion consensus on Wall Street. Medtronic said the decline was mainly driven by its divestiture of multiple business to Cardinal Health earlier this year. Medtronic said it was able to limit the impact of Hurricane Maria against its origi...
Source: Mass Device - November 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Medtronic Source Type: news

Heart valve replacement success may depend on age, valve type
(Reuters Health) - People who need a heart valve replaced often face a dilemma: should they have a mechanical valve made of graphite or a biological valve derived from a cow or pig? A new study suggests the answer depends on the age of the patient and which of the heart ’s valves needs to be replaced. (Source: Reuters: Health)
Source: Reuters: Health - November 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Japan clears Abbott ’ s Mitraclip
Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation. Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added. The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Abbott Source Type: news

Abbott's MitraClip Approved as First Transcatheter Mitral Valve Repair Device in Japan
First minimally invasive device to treat people in Japan with common leaky heart valve for whom surgery is too risky More than 50,000 patients worldwide have been treated with the MitraClip therapy ABBOTT PARK, Ill., Nov. 6, 2017 -- (Healthcare Sales... Devices, Interventional, Cardiology, Regulatory Abbott, MitraClip, Mitral Valve Repair, mitral regurgitation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 6, 2017 Category: Pharmaceuticals Source Type: news

Neovasc surges on news of appeal, FDA nod for clinical trial
Neovasc (NSDQ:NVCN) shares surged today in pre-market trading after the replacement heart valve maker said it’s exhausted the appeals process in its trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve and that it won an FDA nod for a clinical trial. A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal judge in ...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Legal News Replacement Heart Valves CardiAQ Valve Technologies Edwards Lifesciences Neovasc Inc. Source Type: news

Abbott's MitraClip Approved as First Transcatheter Mitral Valve Repair Device in Japan
- First minimally invasive device to treat people in Japan with common leaky heart valve for whom surgery is too risky (Source: Abbott.com)
Source: Abbott.com - November 6, 2017 Category: Pharmaceuticals Source Type: news

TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke. Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes. Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11....
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

LivaNova swings to Q3 black
LivaNova (NSDQ:LIVN) today swung to profitability during the third quarter and raised its earnings outlook for the rest of 2017, after handily beating the consensus forecast on Wall Street. The London-based medical device company reported profits of $27.8 million, or 57¢ per share, on sales of $309.7 million for the three months ended Sept. 30, compared with losses of -$1.6 million during Q3 2016, for sales growth of 4.9%. Adjusted to exclude one-time items, earnings per share were 93¢, 15¢ ahead of consensus on The Street, where analysts were looking for sales of $300.5 million. “We delivered sol...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

Heart Surgery May Be Safer in Afternoon Than in Morning
Having heart valve replacement later in the day was tied to fewer complications. (Source: NYT Health)
Source: NYT Health - November 1, 2017 Category: Consumer Health News Authors: NICHOLAS BAKALAR Tags: Heart Surgery and Surgeons Source Type: news

TCT 2017: Medtronic touts early Intrepid TMVR results
The post TCT 2017: Medtronic touts early Intrepid TMVR results appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news

TCT 2017: Edwards touts cost savings in Sapien 3
The post TCT 2017: Edwards touts cost savings in Sapien 3 appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver. Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT. One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group ana...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Tiny 'anchor' to fix leaky heart valves - without surgery
Thousands of Britons have leaky heart valves. Olasumbo Yates, 56, (pictured) from London, took part in a trial for a new implant that avoids the need for open surgery. (Source: the Mail online | Health)
Source: the Mail online | Health - October 31, 2017 Category: Consumer Health News Source Type: news

HighLife Medical raises $14m for transcatheter mitral valve replacement
HighLife Medical said today that it raised more than $14 million for the replacement heart valve it’s developing to treat mitral regurgitation. Paris- and Irvine, Calif.-based HighLife said the €12.3 million round was led by European venture capital shop Soffinova Partners, joined by prior backers LivaNova (NSDQ:LIVN) and HighLife founder & CEO Georg Börtlein – who also co-founded CoreValve, the aortic valve replacement company acquired in 2009 by Medtronic (NYSE:MDT) for $700 million. HighLife’s transcatheter mitral valve replacement uses a ring around the diseased valve&rsqu...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat HighLife Source Type: news

Afternoon open heart surgery 'leads to fewer complications'
Conclusion This study found evidence of an effect that's worth investigating further to see if there are real differences in heart muscle function and risk of complications from heart surgery at different times of the day. However, there were some limitations: It took place at a single hospital, with a relatively small number of people undergoing operations. The laboratory study found differences in gene activity that suggested the body clock may play a role in making the heart better able to tolerate loss of oxygen and subsequent re-oxygenation. However, there may be other explanations for these differences. For example, ...
Source: NHS News Feed - October 27, 2017 Category: Consumer Health News Tags: Heart/lungs Source Type: news

Blood flow in the developing heart guides maturation of heart valves
(University of Pennsylvania School of Medicine) Congenital heart valve defects are the most common type of birth defects, the majority of which have no clear genetic cause, suggesting that epigenetic factors play an important role. Now, researchers have found that the shear force of blood flow against the cells lining the early heart valve sends signals for heart 'cushion' cells to become fully formed valves. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 26, 2017 Category: International Medicine & Public Health Source Type: news

Congress approves disaster relief bill, $5B slated to support Puerto Rico
US Congress this week approved a $36.5 billion emergency relief bill that will give Puerto Rico access to $4.9 billion in treasury loans to support continued Hurricane Maria recovery efforts in the region, according to a Bloomberg report. The bill passed the senate in an 82 to 17 vote on Tuesday after being approved 353 to 69 in the House earlier in the month, and now awaits the President’s signature. Medtech industry group AdvaMed lauded the bill, saying that it will help ensure that medical device manufacturing facilities “get back to 100% as quickly as possible and continue to supply these important products...
Source: Mass Device - October 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News AdvaMed Capitol Hill Source Type: news

TAVR: Boston Scientific ’ s Acurate Neo, Edwards ’ Sapien 3 show similar results at 30 days
Outcomes from transcatheter aortic valve replacement procedures with both Boston Scientific‘s (NYSE:BSX) Acurate Neo and Edwards Lifesciences‘ (NYSE:EW) Sapien 3 have been found to be similar at 30 days, according to a new study reported by Healio. Results from the trial were published in the journal JACC: Cardiovascular Interventions, according to the report. The study explored the use of both Edwards’ balloon-expandable valve and Boston Scientific’s self-expanding valve in a total of 933 patients undergoing TAVR procedures. The study analyzed 622 patients treated with Edwards Sapien 3 and 311...
Source: Mass Device - October 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news

New method helps rule out heart valve infection
(Lund University) A risk assessment system developed by researchers at Lund University in Sweden shows which patients, with a certain type of streptococcal bacteria in the blood, need to be examined for a heart valve infection -- a serious condition requiring prolonged medical treatment. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 25, 2017 Category: International Medicine & Public Health Source Type: news

Edwards Lifesciences slides on Q3 sales, earnings misses
Edwards Lifesciences (NYSE:EW) missed the mark with its third-quarter sales and earnings, despite posting healthy, double-digit increases to both the top and bottom line, sending share prices down today in after-market trading. The Irvine, Calif.-based implantable heart valve maker posted profits of $170.1 million, or 79¢ per share, on sales of $821.5 million for the three months ended Sept. 30, for a bottom-line gain of 20.3% on sales growth of 11.1% compared with Q3 2016. Adjusted to exclude one-time items, earnings per share were 84¢, two pennies shy of the consensus estimate on Wall Street, where analyst...
Source: Mass Device - October 24, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants MassDevice Earnings Roundup Wall Street Beat Edwards Lifesciences Source Type: news

Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week. In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures. Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints ...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Medtech Industry Frowns on India Price Caps
In response to India’s price capping for certain medical devices, medtech industry group AdvaMed is calling for the perks India enjoys under the U.S. Generalized System of Preferences (GSP) to be withheld. This year, India’s National Pharmaceutical Pricing Authority (NPPA) implemented price caps on coronary stents and knee implants. The coronary stent pricing control went into effect in February 2017 and was followed in August by pricing control on knee implants. The price caps inflicted steep cuts ranging from 70%–85%. Now, AdvaMed has filed a petition with the U.S. Trade Representative asking for India&...
Source: MDDI - October 18, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

The List: Top Austin-area medical device companies
The 2017 list of medical device companies focuses on Austin-area companies that make and sell tools, implants and other devices used in the medical realm to treat patients. Eligible firms must have offices in the Austin area. List includes varied types of companies making medical-related products, such as prosthetics, heart valves, spinal implants, diagnostic test kits. Also included are medical tools and supporting software for clinical research aggregation, analytics and diagnostics. The ABJ surveys companies annually. Only firms that respond to requests for information are included. See also ABJ related list of Bioscien...
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 17, 2017 Category: Pharmaceuticals Source Type: news

The List: Top Austin-area medical device companies
The 2017 list of medical device companies focuses on Austin-area companies that make and sell tools, implants and other devices used in the medical realm to treat patients. Eligible firms must have offices in the Austin area. List includes varied types of companies making medical-related products, such as prosthetics, heart valves, spinal implants, diagnostic test kits. Also included are medical tools and supporting software for clinical research aggregation, analytics and diagnostics. The ABJ surveys companies annually. Only firms that respond to requests for information are included. See also ABJ related list of Bioscien...
Source: bizjournals.com Health Care:Biotechnology headlines - October 17, 2017 Category: Biotechnology Source Type: news

High blood pressure: Condition causes BLOOD to move the WRONG way through heart
HIGH blood pressure could be causing a common heart valve disorder, scientists have revealed. (Source: Daily Express - Health)
Source: Daily Express - Health - October 17, 2017 Category: Consumer Health News Source Type: news

Boston Scientific, Mayo Clinic file joint patent for self-centering TAVR cath
Boston Scientific (NYSE:BSX) and the Mayo Clinic recently filed a joint patent application for a new ‘self-centering’ catheter device as a result of a collaborative development deal the two announced last March, according to a Twin Cities Business Magazine report. The new device is being designed to help improve heart valve replacement surgery by improving the process of threading guide wires through shrunken and often times shifted aortic valve openings in calcified hearts, according to the report. Currently, surgeons must probe along the surface of the valve with the guide wire to find the opening, ...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Replacement Heart Valves Research & Development Boston Scientific Mayo Clinic Source Type: news

Cell-free heart valve offers promise of normal life
EU-funded researchers have developed and tested a way to make human heart valve implants more tolerable and longer lasting, enabling recipients of all ages to avoid follow-up surgery and live largely normal lives, cutting hospital stays and healthcare costs. (Source: EUROPA - Research Information Centre)
Source: EUROPA - Research Information Centre - October 11, 2017 Category: Research Source Type: news

Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company. Edwards has incorporated the taller skirt initially with sizes 20, 23 and ...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news

Transcatheter heart valve surgery simulator dev FEops raises $7m
Surgical simulation software developer FEops said today it raised $7.2 million (EU €6 million) in funding to support its HeartGuide transcatheter valve implantation simulation software. The round was led by newly invested Valiance and joined by existing investors Capricorn and PMV, the Gent, Belgium-based company said. FEops’ flagship product is the HeartGuide platform, which use advanced computer simulations to provide both clinicians and valve manufacturers with insights into the interaction between valves and patient anatomy preoperatively to improve clinical outcomes, the company claims. “The shift tow...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Software / IT Surgical feops Source Type: news

Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve ...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Q & amp;A: How to Control Development Costs for Implantables
When it comes to implantable devices, the material makeup of the technology is not only critical to the success of the device, but it also has a significant impact on the cost. Often times implantables need to be able to survive some of the harshest conditions in the body, where any kind of unexpected breakdown in materials can have critical adverse effects if they aren’t safely designed. This, of course, leaves many device makers with a very short list of potential materials. Len Czuba is president of Czuba Enterprises, a Chicago, IL-based medical device development consultancy that specializes in helping manufactur...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: MD & M Minneapolis Implants Materials Source Type: news

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

Dental Work Tied to Heart Infections in People With Artificial Valves Dental Work Tied to Heart Infections in People With Artificial Valves
Invasive dental procedures may raise the risk of rare but serious infections in people who have prosthetic heart valves, a recent French study suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 15, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Dental work tied to heart infections in people with artificial valves
(Reuters Health) - Invasive dental procedures may raise the risk of rare but serious infections in people who have prosthetic heart valves, a recent French study suggests. (Source: Reuters: Health)
Source: Reuters: Health - September 14, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

AtriCure launches AtriClip Pro-V in the US
AtriCure (NSDQ:ATRC) said today it launched its AtriClip Pro-V left atrial appendate exclusion system in the US. The newly launched AtriClip Pro-V is designed to be placed through a minimally-invasive surgery and features an open-ended design and tip-first closure mechanism for easier navigation, the Mason, Ohio.-based company claims. “Development of the AtriClip Pro-V is another step in the direction of a comprehensive strategy for management of the left atrial appendage. It expands the options for minimally invasive approaches including right chest access and an easier implantation of an epicardial atrial appe...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves AtriCure Inc. Source Type: news

NeoVasc shares surge 45% on affirmed Tiara patent case decision against Edwards
Neovasc (NSDQ:NVCN) saw its shares jump 45% today after a federal appeals court upheld a district court ruling in a trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve, affirming a decision not to enjoin its Tiara program. With the decision, Neovasc will be required to pay the full judgement of approximately $112 million to Edwards, of which the company said $70 million is already held in an escrow account. The Vancouver-based company said that “there are no other monetary damages arising from the award,” and announced that it will remain the joint inventor of its &lsqu...
Source: Mass Device - September 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Legal News Replacement Heart Valves Neovasc Inc. Source Type: news

NaviGate touts 1st 52mm transcatheter tricuspid valve procedure
NaviGate Cardiac Structures touted this week that its Gate catheter-guided tricuspid atrioventricular valved stent was implanted six weeks ago into a patient’s transplanted heart. The patient’s transplanted heart was failing due to severe tricuspid valve insufficiency. The successful implantation at the Policlinico of the University of Padua, Italy, is the first European-based patient treated with the company’s tricuspid replacement heart valve. Three hours after the procedure, the patient was showing improved renal function, NaviGate reported. Two months after the intervention, the 67-year-old male patie...
Source: Mass Device - September 1, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Implants Cardiovascular NaviGate Cardiac Structures Inc Source Type: news

Viagra Won't Help, and May Harm, Patients With a Heart Valve Disorder
Title: Viagra Won't Help, and May Harm, Patients With a Heart Valve DisorderCategory: Health NewsCreated: 8/29/2017 12:00:00 AMLast Editorial Review: 8/30/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - August 30, 2017 Category: Cardiology Source Type: news

Study: Viagra may harm, not help, patients with heart valve disorder
New research suggests Viagra (sildenafil) might raise patients' risk of " pulmonary hypertension linked to valvular heart disease. " (Source: Health News - UPI.com)
Source: Health News - UPI.com - August 30, 2017 Category: Consumer Health News Source Type: news

Viagra May Harm Patients With Heart Valve Issue
Earlier data suggested the drug might ease high blood pressure in lungs, but new study refutes that (Source: WebMD Health)
Source: WebMD Health - August 29, 2017 Category: Consumer Health News Source Type: news

Viagra Won't Help, and May Harm, Patients With a Heart Valve Disorder
TUESDAY, Aug. 29, 2017 -- When one of the heart's valves goes awry, this can lead to dangerously high blood pressure in the nearby lungs. Recent studies have suggested that the impotence drug Viagra (sildenafil) might help ease the problem, known... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 29, 2017 Category: General Medicine Source Type: news

Which TAVR patients are at risk for hospital readmission?
(University at Buffalo) As more elderly patients undergo the minimally invasive heart valve procedure called Transcatheter Aortic Valve Implantation (TAVR), concerns have been raised as to what causes some to be readmitted for heart failure after the procedure. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 25, 2017 Category: International Medicine & Public Health Source Type: news

Death rates from rheumatic heart disease falling since 1990
(Institute for Health Metrics and Evaluation) The risk of dying from rheumatic heart disease, a condition of damaged heart valves caused by bacterial infection that leads to rheumatic fever, has dropped around the world over the last 25 years, according to a new scientific study published today in The New England Journal of Medicine. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - August 23, 2017 Category: International Medicine & Public Health Source Type: news

Bristol scientists to study oral bacteria that cause heart valve infection
Scientists at the University of Bristol are investigating how bacteria in our mouth can cause a heart problem, called infective endocarditis. Although uncommon, infective endocarditis is a serious condition that can often be fatal. (Source: University of Bristol news)
Source: University of Bristol news - August 21, 2017 Category: Universities & Medical Training Tags: Health, International, Grants and Awards, Research; Faculty of Health Sciences, Faculty of Health Sciences, Bristol Dental School; Press Release Source Type: news

BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency due to the congenital bicuspid aortic valve malformation in which the aortic valve forms with only 2 functional valve leaflets instead of 3. Bicuspid aortic valve malformations affect up to 2% of the population and carry a signi...
Source: Mass Device - August 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves BioStable Science & Engineering Source Type: news