JenaValve launches CE Mark study of next-gen TAVR system
JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter. In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for conventional surgical valve replacement. “There is currently no TAVR treatment for severe aortic regurgitation cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVR valves that rely on t...
Source: Mass Device - June 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves JenaValve Source Type: news

Reduced-Intensity Warfarin Safe With On-X Heart Valve Reduced-Intensity Warfarin Safe With On-X Heart Valve
Low-dose warfarin plus aspirin was associated with less bleeding without increasing thromboembolic events compared with standard-dose warfarin after aortic valve replacement with the On-X mechanical valve.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 21, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said. “Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. The new larger sizes allow us to treat more ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance LivaNova Source Type: news

Venus Medtech launches Venus pulmonary valve implant
Chinese heart valve maker Venus Medtech said today it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region. The Venus P-Valve was designed for percutaneous use in native right ventricular outflow tracts, the Hangzhou-baesd company said, and is intended for patients who wish to avoid sternotomy and cardiopulmonary bypasses associated with traditional valve replacement surgeries. The first procedures were performed on two patients who had previously been treated with surgical patch correction for tetralogy of ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Replacement Heart Valves Venus Medtech Source Type: news

LivaNova wins Japanese nod for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve designed to treat aortic valve disease. The London-based company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions. “With this approval for Perceval, an innovative and trusted valve platform, we ar...
Source: Mass Device - June 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves LivaNova Source Type: news

TriCares raises $26m Series B for tricuspid valve program
TriCares said today that it raised nearly $26 million in a Series B round for the tricuspid valve replacement technology it’s developing. Paris- and Munich-based TriCares said the €22 million ($25.8 million) round was led by new backers Wellington Partners, Andera Partners and BioMed Partners, plus existing investors CM-CIC Innovation, CapDecisif Management and GO Capital. Proceeds from the round are slated to go toward product development, clinical trials and a bid for CE Mark approval in the European Union, the company said. “We believe the unique design of our heart valve prostheses will ...
Source: Mass Device - June 4, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat TriCares Source Type: news

Pioneering keyhole procedure that seals leaking heart valves
People left breathless and even housebound by a common heart condition can now benefit from a pioneering keyhole procedure that spares them the ordeal of open surgery (Source: the Mail online | Health)
Source: the Mail online | Health - June 2, 2018 Category: Consumer Health News Source Type: news

Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device. In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the Israel-based company said. “Knowing what we now know about the significant risks of stroke and other neurological injury associated with TAVR and other cardiovascular procedures, there is a clear unmet clinical need for cerebral embolic protection devi...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Neurological Keystone Heart Source Type: news

JC Medical Becoming Serious Challenger in TAVR Fray
Edwards Lifesciences and Medtronic have been at the forefront of the transcatheter aortic valve replacement (TAVR) market for a few years now. However, as time goes on, the two companies are facing increasing competition from a  number of challengers. These companies aren’t necessarily new – but they have passed the test of time to put them on the field of being relevant in the market. The latest company to show margins of success is privately held firm, JC Medical, which was formed in 2009. On Thursday, the Burlingame, CA-based company said it had treated the first patient with the J-Valve TF System ...
Source: MDDI - May 31, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report. Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did not reduce mortality, but was associated with a lowered rate of stroke at 30 days, according to the report. The decline was mainly driven by registry data and was not confirmed by randomized controlled trials, Medscape specified. Stroke was repo...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Claret Medical Inc. Source Type: news

JC Medical touts first-in-human use of transfemoral J-Valve TAVI
JC Medical today announced the first clinical procedure using its transfemoral J-Valve TF transcatheter aortic valve implant system designed to treat aortic regurgitation. The procedure, performed at Vancouver’s St. Paul’s Hospital by Dr. John Webb, marks the first in-human use of the transfemoral TAVI device, the China-based company said. JC Medical’s J-Valve System is designed to restore normal blood flow out of the heart and into the body, which may improve symptoms of heart failure such as shortness of breath, fatigue and chest pain, the company said. The devices feature a proprietary anchor mechanism...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Replacement Heart Valves JC Medical Source Type: news

NOTION: TAVR Still Holds Sway in Low-Risk Patients at 6 Years NOTION: TAVR Still Holds Sway in Low-Risk Patients at 6 Years
Hemodynamic valve performance was superior after TAVR compared with surgical aortic valve replacement, and structural valve deterioration was also significantly lower.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 29, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

EuroPCR 2018 Roundup: Edwards reportedly pauses Centera valve EU launch
Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting. Delivery of the unit and its use in clinical cases are slated to resume during the third quarter, according to the letter, with Edwards claiming there will be no impact on its financial guidance for the year. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized deli...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Edwards Lifesciences Source Type: news

Venus Medtech inks exclusive TriGuard 3 deal with Keystone Heart
Chinese heart valve maker Venus Medtech said yesterday it inked a partnership deal with Keystone Heart through which Venus will gain exclusive rights to develop and sell a third-gen version of Keystone’s TriGuard 3 device in China and other Asian markets. The deal builds on a partnership between the two companies announced last March to promote Venus’ TAVR system, the Venus A-Valve, in combination with Keystone Heart’s 1st-gen TriGuard cerebral embolic protection device in China and other major Asian markets. “Venus Medtech is not solely focused on transcatheter valve products. We care abo...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological Replacement Heart Valves Research & Development Keystone Heart Venus Medtech Source Type: news

Real World Data Could Give Edwards Edge in TAVR
Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR. The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. Nearly 2,000 patients were involved and treated in more than 450 commercial centers around the U....
Source: MDDI - May 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follo...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news

8 companies commercializing transcatheter mitral valve replacements
[Images from Edwards Lifesciences, Highlife Medical and Abbott]Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used to treat mitral regurgitation, which is a leakage of blood backward through the mitral valve each time the left ventricle closes. According to the American Hea...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiac Implants Cardiovascular Replacement Heart Valves 4cmedical Abbott Boston Scientific Edwards Lifesciences HighLife LivaNova MedTech Medtronic Neovasc Inc. TMVR transcatheter mitral valve replacement Source Type: news

NaviGate touts “ excellent ” valvular function at 1 year with Gate tricuspid valve
NaviGate Cardiac Structures Inc today touted that the first patient to receive its Gate tricuspid valved stent through a transjugular access procedure under compassionate use protocols has reached one year post-procedure and still maintains excellent valvular function. The procedure was performed last April at the Cleveland Clinic, the Lake Forest, Calif.-based company said. At one year, the patients’ bioprosthesis is demonstrating “excellent leaflet mobility and valve function,” NaviGate said. A total of 16 patients have been treated with the valve for severe tricuspid regurgitation, the company sai...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves NaviGate Cardiac Structures Inc Source Type: news

Venus Medtech wins backing from DCP Capital
Chinese heart valve maker Venus Medtech said yesterday it inked a definitive investment agreement with DCP Capital to support the upgrading and internationalization of its valve products. Through the deal, DCP Capital will also support clinical research into a new mitral and tricuspid valve disease treatment technology as the company looks to make a more solid entry into the international heart valve market, Venus Medtech said. “DCP is delighted to have the opportunity to invest into Venus Medtech. We are extremely impressed with the company’s outstanding management team, strong technological cap...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Venus Medtech Source Type: news

CoreMedic launches first-in-human study of ChordArt mitral repair device
German medtech developer CoreMedic this week announced the launch of a first-in-man trial of its ChordArt mitral valve repair device, touting the trial as the first of its kind to treat patients with ruptured or elongated mitral chords. The company’s ChordArt implant is designed to replace ruptured or elongated mitral chordae and to re-establish the connection of the valve leaflets with the papillary muscle to restore functionality. In the trial, researchers will explore the use of the system in up to 40 patients at six European centers, CoreMedic said. “The first clinical use of ChordArt is a major milestone i...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials coremedic Source Type: news

Ancora Takes on FMR and Heart Failure with AccuCinch
Ancora Heart is making a play for the functional mitral regurgitation (FMR) treatment market – which is currently populated by medtech juggernauts Abbott Laboratories and Edwards Lifesciences. The Santa Clara, CA-based company came closer to its goal to participate in the market after it received FDA approval to expand the enrollment for an early feasibility study of the AccuCinch. Ancora Heart said it can now enroll a second group of patients and expand to 15 heart centers across the U.S. “The AccuCinch System is a left ventricular repair technology and it really is a new category and class of therapy,” ...
Source: MDDI - May 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

Neovasc Sales Significantly Down for the Quarter
Neovasc, one of the smaller players in the transcatheter mitral valve replacement (TMVR) space, has seen a huge decrease in revenues, according to results posted in its most recently recorded earnings quarter. The Vancouver-based company said revenues declined by 77% from $339, 922 for the first quarter of 2018 compared to revenues of $1.5 million from the same period in 2017. "Despite a challenging period for our shareholders, we are encouraged by our improved financial position through the receipt of $12.3 million in proceeds from investor-initiated exercises of Series C warrants that were issued during our Nov...
Source: MDDI - May 14, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

#MayoClinicRadio podcast: 5/12/18
Listen: Mayo Clinic Radio 5/12/18 On the Mayo Clinic Radio podcast, Dr. Charanjit Rihal, a cardiologist at Mayo Clinic, discusses aortic valve disease and options for?valve repair and replacement.?Also on the podcast, Dr. Alice Gallo De Moraes, a critical care specialist at Mayo Clinic, explains how Rapid Response Teams help hospitalized patients get critical care [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - May 14, 2018 Category: Databases & Libraries Source Type: news

Study: Researchers create new tissue-engineered valve that mimics the heart
Researchers have created a new prosthetic heart valve intended to closely mimic the functionality and properties of natural heart valves, according to a study posted to Science Translational Medicine. Investigators in the study hope the new valve will help overcome issues that have held back previous tissue-engineered heart valves. The valve, designed from polymer scaffolds seeded with vascular cells and allowed to grow in a bioreactor culture, was decellularized and implanted in a transcatheter procedure in an animal test. Researchers monitored the valve for a year across 11 separate implantations, and found that after 12...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Replacement Heart Valves Research & Development Source Type: news

Computer-Designed Customized Regenerative Heart Valves
Producing living tissue or organs based on human cells is one of the main research fields in regenerative medicine. Tissue engineering, which involves growing replacement parts in the laboratory, forms a key part of this research. The parts can be used to replace defective cells and tissues in the body and restore their normal functioning. (Source: eHealth News EU)
Source: eHealth News EU - May 10, 2018 Category: Information Technology Tags: Featured Research Research and Development Source Type: news

Abbott wins FDA nod for Advisor HD Gridcardiac mapping cath
Abbott (NYSE:ABT) said today it won FDA clearance for is Advisor HD Grid mapping sensor enabled catheter designed for creating highly detailed maps of the heart. The newly cleared mapping catheter builds on the Abbott Park, Ill.-based company’s previous designs and and is intended to improve cardiac ablation procedures by providing an inside view of the heart for more accurate identification of the cardiac anatomy. The Advisor HD Grid catheter is designed to capture data including the direction and speed of cardiac signals, and allows for the creation of high-density maps of cardiac tissue for more optimal ...
Source: Mass Device - May 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

LivaNova shares down despite Street-beating Q1
Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker beating the Street on earnings per share and sales with its first quarter earnings results. The London-based company posted profits of $13.3 million for the three months ended March 31, seeing 17.7% growth on the bottom-line while sales grew by 10.4% compared with the same period during the previous year. Adjusted to exclude one-time items, earnings per share were 68¢, just ahead of the 65¢ consensus on Wall Street where analysts expected too see sales of $243.4 million, which the company also topped. “We are continuing our posi...
Source: Mass Device - May 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

Medtronic expands paid family leave benefits for US employees | Personnel Moves – May 1, 2018
Medtronic (NYSE:MDT) today announced expanded paid family leave benefits which the company says will “allow for greater employee flexibility while balancing work and family priorities.” The new benefits, which went into effect today, cover full and part-time US employees and allow for a “wide range of family care leave needs,” the Fridley, Minn.-based company said. These include time spent with a new child, caring for sick family members or caring for family after a spouse, child or parent is called to active military duty. “These expanded benefits support our employees and their families...
Source: Mass Device - May 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Admedus Ltd. bectondickinson crbard Medtronic Minnetronix Inc. Zeus Industrial Products Source Type: news

Edwards Lifesciences wins CE Mark for Cardioband transcath tricuspid valve system
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Cardioband transcatheter tricuspid valve reconstruction system, touting it as the first commercially cleared transcath therapy for treating tricuspid heart valve disease. The Cardioband tricuspid system is designed to be delivered through a transfemoral approach and is intended to reduce tricuspid regurgitation through annular reduction, the Irvine, Calif.-baed company said. The system features the same design and implant technique as the company’s Cardioband mitral system. “Although open-heart surgical val...
Source: Mass Device - April 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

After Stroke, Delaying SAVR Cuts Risk for New Stroke After Stroke, Delaying SAVR Cuts Risk for New Stroke
The recurrent-stroke risk truly spikes at surgical aortic valve replacement within 3 months of a prior stroke, say researchers of a cohort study, cautioning that such SAVR be delayed'at least 3 or 4 months. 'Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - April 27, 2018 Category: Cardiology Tags: Cardiology News Source Type: news

Post-approval registry shows positive 1-year results for Abbott ’ s MitraClip
A post-approval registry study of the MitraClip mitral valve repair device from Abbott (NYSE:ABT) showed positive results at one year, according to late-breaking results presented this week at the annual meeting of the Society for Cardiovascular Angiography & Interventions in San Diego. The real-world study, of the first 2,000 MitraClip patients treated in the Transcatheter Valve Therapy Registry, showed that 86.8% of patients had post-procedural mitral regurgitation of ≤2+ and a survival rate of 81.7% after a year. Echocardiograms showed improvement in left ventricular end-diastolic volume and left v...
Source: Mass Device - April 27, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Abbott Source Type: news

Previous Stroke Tied to Higher Risks in Aortic Valve Replacement
FRIDAY, April 27, 2018 -- For patients undergoing surgical aortic valve replacement (SAVR), previous stroke is a risk factor for recurrent ischemic stroke and major adverse cardiovascular events (MACE), according to a study published online April 25... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 27, 2018 Category: Pharmaceuticals Source Type: news

First ever risk tool predicts readmission rates for patients after undergoing TAVR
(Society for Cardiovascular Angiography and Interventions) A new study looked at the effectiveness of novel risk tool to predict 30-day readmission rates in patients undergoing transcatheter aortic valve replacement (TAVR) presented today at SCAI 2018 Scientific Sessions. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - April 27, 2018 Category: International Medicine & Public Health Source Type: news

Medtronic touts two-year Harmony transcath pulmonary valve feasibility study data
Medtronic (NYSE:MDT) today released two-year outcomes from an early feasibility study of its Harmony transcatheter pulmonary valve, touting solid valve function no reports of paravalvular leaks. Results were presented at the Society for Cardiovascular Angiography and Interventions 41st annual scientific sessions, the Fridley, Minn.-based company said. “Following the one-year feasibility outcomes, we are encouraged to see the Harmony valve continues to show positive outcomes for patients two years post-implant. We are optimistic that these early outcomes will be a strong indicator of the types of results that we ...
Source: Mass Device - April 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Cardiac Dimensions anchors $39m Series B for Carillon mitral repair device
Cardiac Dimensions said today that it raised a $39 million Series B round for the Carillon mitral valve repair device it’s developing. Kirkland, Wash.-based Cardiac Dimensions said the round was led by a new Australian backer, Hostplus, and included a venture debt contribution from Oxford Finance. Existing investors M. H. Carnegie, Arboretum Ventures, Lumira Capital, LSP Health Economics Fund and Aperture Venture Partners also got in on the round, the company said. The percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, t...
Source: Mass Device - April 26, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Cardiac Dimensions Inc. Source Type: news

New study shows life-saving outcomes using 3-D printing models for heart valve disease
(Society for Cardiovascular Angiography and Interventions) A new study examines the effectiveness of 3-D printing technology and computer modeling to predict paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 26, 2018 Category: International Medicine & Public Health Source Type: news

Are the Odds Ever in Edwards & #039; Favor in the TAVR Games?
With competition picking up in the transcatheter aortic valve replacement (TAVR) space, it's easy to wonder if Edwards Lifesciences will continue to be the market victor. The company's stock price dipped this week after Edwards posted first-quarter results that fell short of consensus expectations. But to borrow a popular phrase from Suzanne Collins' Hunger Games trilogy, there is still plenty of reason to believe that the odds may be ever in Edwards' favor. Here are the key takeaways from the company's earnings call, as transcribed by Seeking Alpha, along with analyst comments. 1. Medtronic's royalty payment rat...
Source: MDDI - April 25, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Delay SAVR After Stroke, Study Suggests
(MedPage Today) -- Aortic valve replacement within 3 months associated with big risk (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - April 25, 2018 Category: Cardiology Source Type: news

Getting in on the Embolic Protection Action for TAVR
There has been an increase in the need for embolization protection devices as the risk for stroke and other neurological damage from transcatheter aortic valve replacement (TAVR) procedures continues to become more prevalent.   Santa Cruz, CA -based Emboline is looking to enter the embolization protection space, which is set to grow from $406 million this year to $605 million by 2023, according to a report from ResearchandMarkets. The emerging medtech company's contribution to the space would come from its Emboliner Embolic Protection Catheter.  The Emboliner is a cylindrical mesh filter that completely...
Source: MDDI - April 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures. The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commerciali...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news

HeartStitch wins CE Mark for CoAp Pro mitral valve repair device
HeartStitch said today it won CE Mark approval in the European Union for its CoAp Pro device designed for mitral valve remodeling and repair. The Fountain Valley, Calif.-based company said its CoAp Pro device is designed to allow physicians to remodel mitral valve leaflets to re-establish proper coaptation. “I am especially pleased to see HeartStitch receive this approval, because it provides the ability to use suture to remodel the mitral valves rather than the need to place a prosthetic device in the leaflets. In my opinion it is a significant advancement to the treatment of mitral regurgitation. Personally, I...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance HeartStitch Source Type: news

Delayed Coronary Obstruction Rare After TAVR
THURSDAY, April 19, 2018 -- Delayed coronary obstruction (DCO) after transcatheter aortic valve replacement (TAVR) is a rare phenomenon but is associated with a high in-hospital mortality rate, according to a study published in the April 10 issue... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 19, 2018 Category: Pharmaceuticals Source Type: news

A molecular atlas of calcific aortic valve disease
(Brigham and Women's Hospital) A team of researchers from BWH has comprehensively analyzed gene expression and protein distribution in human aortic valves obtained from valve replacement surgery. Their results are published in Circulation. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 18, 2018 Category: International Medicine & Public Health Source Type: news

European Patent Office revokes Edwards Lifesciences patent in TAVR spat with Boston Scientific
Boston Scientific (NYSE:BSX) said today that the European Patent Office revoked a patent owned by Edwards Lifesciences (NYSE:EW) in the latest round of their ongoing spat over transcatheter aortic valve replacements. In March 2017 a German court issued a mixed decision in the international battle over transcatheter aortic valve replacement patents between the two companies, less than a week after a U.K. patent court handed down a similar decision. Yesterday Boston said it’s confident that the new EPO decision “will have a positive impact on both suits.” Meanwhile the U.K. Hig...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Patent Infringement Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news

HeartStitch wins CE Mark for Trans-Apical Access and Closure device
HeartStitch said today it won CE Mark approval in the European Union for its suture-based Trans-Apical Access and Closure device. The Trans-Apical Access and Closure device is designed to provide percutaneous trans-apical access for structural heart procedures and closures. The system emulates surgical closure without need for open heart surgery or limited thoractomy access during left-heart structural heart defect repairs, the company said. “The CE Mark approval is another major step in the continuing process of establishing HeartStitch in the market as an innovator in the field of structural heart repair....
Source: Mass Device - April 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance HeartStitch Source Type: news

Neovasc raises $7m in warrants offering
Neovasc (NSDQ:NVCN) said today that it raised more than $7 million in a warrants offering. Vancouver-based Neovasc said the offering, of nearly 4.9 million Series C warrants at an exercise price of $1.46 apiece, resulted in gross proceeds of $7.1 million. “This receipt into treasury is significant. We believe it is sufficient to substantially fund the company for an additional four months at our current burn rate, until approximately early 2019, and increases our current cash on hand by almost 60%,” CFO Chris Clark said in prepared remarks. Last year Neovasc, which is developing a transcatheter mitral valv...
Source: Mass Device - April 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Neovasc Inc. Source Type: news

This 3-year-old has ‘ a sparkle ’ in her heart: The world ’ s smallest mechanical heart valve
When Sadie Rutenberg was born, she had a gaping hole between the two sides of her heart, and her heart valves were malformed and leaking. In her first few months of life, she had already undergone two open-heart surgeries; but the damage was too extensive to repair, and the blond-haired, blue-eyed infant was failing to thrive. Her parents said there […]Related:FDA restricts sale of Essure contraceptive device, requires that women be informed of risksWith $2 million, Kaiser Permanente wants to help revive underfunded gun-violence researchThe CDC researcher who mysteriously vanished in Februar...
Source: Washington Post: To Your Health - April 11, 2018 Category: Consumer Health News Source Type: news

JenaValve Is a Growing Force to be Reckoned with in TAVR
It would be a big mistake to leave JenaValve out of the transcatheter aortic valve replacement (TAVR) market conversation. The Munich, Germany-based company has been biding its time and reaching milestones, in the hopes of obtaining some serious market share in the TAVR space. The small company's latest achievement is successfull enrollment in the CE mark study of the next generation of JenaValve Pericardial TAVR system. “It’s very tricky to develop a TAVR system because it can take several iterations before you can get it right,” Victoria Carr-Brendel, JenaValve CEO, told MD+DI. “We think we ...
Source: MDDI - April 11, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

HeartStitch touts tricuspid repair feasibility cases
Structural heart focused medtech company HeartStitch said today that its HeartStitch Remo Pro suture technique was used in a world first procedure to repair the tricuspid valve of two patients as part of a feasibility trial of the technique and the supporting technology. The procedures were performed by Dr. Yuri Pya at Astana, Kazakhstan’s National Research Cardiac Surgery Center, the company said. Both patients in the trial required tricuspid heart valve repair to remodel the annulus of their tricuspid valve to treat tricuspid regurgitation. Patients in the feasibility test tolerated the procedure and have been...
Source: Mass Device - April 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials HeartStitch Source Type: news

Procedure makes heart valve replacement safer for high-risk patients
Scientists developed a novel technique that prevents a rare but often fatal complication that can arise during a heart valve procedure called transcatheter aortic valve replacement. (Source: NIH Research Matters from the National Institutes of Health (NIH))
Source: NIH Research Matters from the National Institutes of Health (NIH) - April 10, 2018 Category: Consumer Health News Source Type: news