Over-allotment takes Hancock Jaffe IPO to nearly $9m
The underwriter of an initial public offering by Hancock Jaffe Laboratories (NSDQ:HJLI) this week exercised in full its over-allotment option, taking the gross proceeds from the flotation to nearly $9 million. The IPO, which priced on the last day of May, initially brought in $7.5 million for Irvine, Calif.-based Hancock Jaffe, which makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass grafts. The shares trade on the NASDAQ exchange under the symbol “HJLI.” Network 1 Financial Securities, the offering’s managi...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Initial Public Offering (IPO) Vascular Wall Street Beat hancockjaffelabs 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

Superbug Infections Rising Among Injection Drug Users
NEW YORK (AP) — One type of superbug bacteria is increasingly spreading among people who inject drugs, according to a new government report. Users of heroin and other injection drugs were 16 times more likely than other people to develop severe illnesses from MRSA, said the report published Thursday. "Drug use has crept up and now accounts for a substantial proportion of these very serious infections," said Dr. William Schaffner of Vanderbilt University, one of the study's authors. The U.S. is in the midst of its deadliest drug epidemic ever. While overdose deaths have been the main concern, some studies ha...
Source: JEMS Patient Care - June 8, 2018 Category: Emergency Medicine Authors: Mike Stobbe, Associated Press Tags: Patient Care News Source Type: news

Superbug Infections Rising Among Injection Drug Users
NEW YORK (AP) — One type of superbug bacteria is increasingly spreading among people who inject drugs, according to a new government report. Users of heroin and other injection drugs were 16 times more likely than other people to develop severe illnesses from MRSA, said the report published Thursday. "Drug use has crept up and now accounts for a substantial proportion of these very serious infections," said Dr. William Schaffner of Vanderbilt University, one of the study's authors. The U.S. is in the midst of its deadliest drug epidemic ever. While overdose deaths have been the main concern, some studies ha...
Source: JEMS: Journal of Emergency Medical Services News - June 8, 2018 Category: Emergency Medicine Authors: Mike Stobbe, Associated Press Tags: Patient Care News 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

Hancock Jaffe prices $8m IPO below the range
Medical device developer Hancock Jaffe Laboratories yesterday priced its initial public offering below the re-set range it issued last week, raising nearly $8 million. Irvine, Calif.-based Hancock Jaffe makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass graft. Last December the company said it planned to float nearly 1.9 million shares at $6 to $8 apiece, for gross proceeds of $11.3 million to $15.0 million, or $13.1 million at the midpoint. But last week Hancock Jaffe cut the amount of shares to roughly 1.1 million...
Source: Mass Device - June 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Initial Public Offering (IPO) Wall Street Beat hancockjaffelabs 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

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

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

Hancock Jaffe re-sets the range for $8m IPO
Medical device developer Hancock Jaffe Laboratories yesterday re-set the range on a pending initial public offering, which would fetch roughly $8 million at the midpoint. Irvine, Calif.-based Hancock Jaffe makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass graft. Last December the company said it planned to float nearly 1.9 million shares at $6 to $8 apiece, for gross proceeds of $11.3 million to $15.0 million, or $13.1 million at the midpoint. In a new filing yesterday, Hancock Jaffe cut the amount of shares to roughly 1.1 m...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Initial Public Offering (IPO) Vascular Wall Street Beat hancockjaffelabs 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

An Egg A Day Might Reduce Your Risk Of Heart Disease, Study Says
In this study however, they didn’t assess the risk of developing diabetes, which may be because diabetes is a newer disease in the Chinese population and there is not good documentation of who has it,” Richard said. Still, she noted, “this will be very important data for helping develop dietary prevention guidelines in China.” Cardiovascular disease, which takes the lives of 17.7 million people every year, is the leading cause of death and disability worldwide, according to the World Health Organization. Cardiovascular disease causes nearly a third — 31% — of all global deaths each year....
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - May 22, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Eggs Heart Disease Local TV Source Type: news

Treatment with Abbott's Portico ™ Transcatheter Aortic Valve Showed Portico is Safe and Reduces Severe Aortic Stenosis at 30 Days in Real-World Setting
- Data presented at EuroPCR indicated excellent clinical outcomes for Portico in a real-world setting to treat common and life-threatening heart valve disease with minimally invasive option (Source: Abbott.com)
Source: Abbott.com - May 22, 2018 Category: Pharmaceuticals 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

Minnesota 2.0: Can this major U.S. medical device cluster become a healthcare innovation hub?
Minnesota has the institutions and the talent to transform healthcare in the U.S. The question is whether the money will follow. RxFunction makes wearable devices called “Walkasins” that help people with chronic health conditions prevent falls that can lead to serious injury. It took eight painstaking years, though, before the Eden Prairie, Minn.-based startup secured the $7.5 million in Series A funding it needed to prepare for the commercialization of its product: Shoe inserts that measure users’ foot pressure and enable immediate sensory cues to control balance. Lars Oddsson, RxFunction’s preside...
Source: Mass Device - May 15, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News mHealth (Mobile Health) News Well Research & Development devicetalksminnesota evergreenmedicaltechnologies lemhiventures Mayo Clinic Medical Alley Assn. pediatricdeviceinnovationconsortium rxfunction universit 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

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

Edwards inks $400m share repurchase deal
Edwards Lifesciences (NYSE:EW) said today it inked a deal to repurchase an aggregate of $400 million in its common shares. Under terms of the new share repurchasing deal, Edwards said it will receive approximately 2.5 million shares this month, with the final number of shares to be repurchased based on the volume weighted average share price during the term of the agreement. Edwards said that as of March 31, it had approximately $1.3 billion authorization remaining on a share repurchase program approved by its board of directors, according to an SEC filing. Yesterday, Edwards said it won CE Mark approval in the Europe...
Source: Mass Device - May 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Edwards Lifesciences Source Type: news

Edwards Granted CE Mark For First Transcatheter Tricuspid Therapy
IRVINE, Calif., April 30, 2018 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction System for the treatment of tricuspid regurgitation. The Cardioband Tricuspid System is the first commercially available transcatheter therapy for the treatment of tricuspid heart valve...This story is related to the following:Medical Devices (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - May 1, 2018 Category: Medical Devices 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

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

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

AHA: How Black Cardiologists Are Combating Heart Valve Disease
THURSDAY, April 26, 2018 (American Heart Association) -- Doctors and African-American communities are obligated to learn more about heart valve disease and the lifesaving procedures available to treat it, according to a report from the Association... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 26, 2018 Category: General Medicine Source Type: news

AHA: How Black Cardiologists Are Combating a Problem Affecting Millions
THURSDAY, April 26, 2018 (American Heart Association) -- Doctors and African-American communities are obligated to learn more about heart valve disease and the lifesaving procedures available to treat it, according to a report from the Association... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 26, 2018 Category: General Medicine 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

Infection of the heart valves and healthcare costs on rise due to impact of IV drug
(Society for Cardiovascular Angiography and Interventions) A new study finds the number of patients hospitalized with endocarditis has increased dramatically over the last decade in a pattern that mirrors the increase in mixed drug use. (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

Edwards Lifesciences shares down on mixed-bag Q1 earnings release
Shares in Edwards Lifesciences (NYSE:EW) have fallen in after-hours trading today after the medical device maker posted first quarter earnings that beat earnings per share expectations, but missed sales consensus on Wall Street and showed shrinking profits. The Irvine, Calif.-based company posted profits of $206.6 million, or 96¢ per share, on sales of $894.8 million for the three months ended March 31, seeing profits shrink 10.3% while sales grew 1.3% compared with the same period during the previous fiscal year. Adjusted to exclude one-time items, earnings per share were $1.22, well ahead of the $1.11 consensus...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Edwards Lifesciences Source Type: news

First toddler to receive world's smallest heart valve 3 years ago
Sadie Rutenberg, three, was born with a life-threatening heart defect in Seattle, Washington, in November 2014. At six months old she became the first baby to receive an experimental heart valve. (Source: the Mail online | Health)
Source: the Mail online | Health - April 23, 2018 Category: Consumer Health News 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

New CDC chief stepped down from four groups to comply with ethics rules
Centers for Disease Control and Prevention Director Robert Redfield has resigned from positions at four groups, including a gene therapy biotechnology company and a conservative AIDS organization, to comply with government ethics rules, according to his financial disclosures. Redfield, a longtime HIV/AIDS researcher who started the job March 26, succeeded Brenda Fitzgerald, the former Georgia […]Related:These are the top priorities for the nation’s top cancer doctorFor advanced lung cancer, immune therapy plus chemo prolongs survivalThis 3-year-old has ‘a sparkle’ in her heart: The world’s sm...
Source: Washington Post: To Your Health - April 17, 2018 Category: Consumer Health News 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

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

Girl thriving after becoming first to get world's smallest mechanical heart valve
A little girl who became the first baby to undergo surgery to connect a miniature, mechanical heart valve in a medical trial is thriving as the FDA approves the valve. (Source: ABC News: Health)
Source: ABC News: Health - April 9, 2018 Category: Consumer Health News Tags: Health Source Type: news

LivaNova closes $250m TandemLife buy
LivaNova (NSDQ:LIVN) said today it closed its $250 million acquisition of cardiopulmonary temporary support solutions developer TandemLife . In the deal, London-based LivaNova said it paid $200 million up front with an additional $50 million to be paid based on specific regulatory milestones. The company said it expects the acquisition to be moderately accretive this year. “The acquisition of TandemLife allows us to complement our portfolio with a complete set of solutions for extracorporeal life support and percutaneous mechanical circulatory support. Expanding our existing line of cardiopulmonary products will...
Source: Mass Device - April 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions LivaNova Source Type: news

This new technique could make TAVR more available
The BASILICA procedure involves (A) a catheter directing an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract; (B) after snare retrieval, the mid-shaft of the guidewire is electrified to lacerate the leaflet (C); (D) the leaflet splays after TAVR permitting coronary flow. [Image courtesy of NIH]A novel technique could prevent coronary artery obstruction — a rare but often fatal complication related to transcatheter aortic valve replacement (TAVR), according to the National Institutes of Health researchers who created it. The researchers at NIH&...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters News Well Replacement Heart Valves Research & Development and Blood Institute NHLBI Edwards Lifesciences Lung National Heart National Institutes of Health (NIH) tavr Source Type: news

Safer heart valve replacement developed for high-risk patients
Researchers have developed a safer method for aortic valve replacement among high-risk patients, the National Institutes of Health announced Monday. (Source: Health News - UPI.com)
Source: Health News - UPI.com - April 3, 2018 Category: Consumer Health News Source Type: news