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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

Medtronic wins expanded FDA nod for Endurant II stent graft
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies. Prior to receiving the clearance, patients with short infra-renal necks were classified as ineligible for endovascular aneurysm repair, the Fridley, Minn.-based company said. Medtronic estimates that 10-13% of AAA patients have AAA proximal neck anatomies of lower than or equal to 10mm. “Due to the complex and hostile proximal ao...
Source: Mass Device - October 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stents Vascular Medtronic Source Type: news

Adding Albumin to Risk Score Improves Mortality Prediction
In patients undergoing transcatheter aortic valve replacement, low albumin tied to higher mortality (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - October 10, 2017 Category: Respiratory Medicine Tags: Cardiology, Family Medicine, Geriatrics, Internal Medicine, Critical Care, Nursing, Pathology, Pulmonology, Surgery, Journal, Source Type: news

Abiomed joins $15m round for acute heart failure treatment dev Magenta Medical
Novel acute heart failure treatment developer Magenta Medical said it closed a $15 million Series B round of financing, joined by transcatheter heart pump dev Abiomed (NSDQ:ABMD). Investors in the Israel-based company included Pitango Venture capital, JAFCO and a group of industry investors led by Dr. Jacques Seguin, who founded CoreValve. Dr. Seguin will also join the company’s board of directors as part of the funding round. Magenta Medical was founded in 2012 and is developing “novel therapeutic approaches to the management and treatment of acute heart failure.” The treatment is based around ...
Source: Mass Device - September 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Abiomed magentamedical 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

Regular Evaluation Improves Survival in Asymptomatic Severe AS Regular Evaluation Improves Survival in Asymptomatic Severe AS
Patients with asymptomatic severe aortic stenosis followed according to guideline recommendations were more likely to undergo early valve replacement and had improved survival and reduced hospitalization.Medscape Medical News (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - September 18, 2017 Category: Radiology Tags: Cardiology News 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

Routine LAA Closure at Heart Surgery: Support From LAACS Routine LAA Closure at Heart Surgery: Support From LAACS
Closing off the left-atrial appendage at CABG or valve surgery, widely done without much of an evidence base, seemed to protect against strokes, symptomatic or silent, in a small randomized trial.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 6, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Hope for Kevin ’s heart: Five-year-old shines after novel treatment for Ebstein’s anomaly
As the lights dimmed and Pharrell Williams’ “Happy” blasted from loudspeakers, Kevin Nolan III took to the stage for his very first dance recital. Sporting striped pants, a turquoise bow tie and a black top hat, Kevin joined his class in performing two hip-hop jazz routines to a packed house. Kevin’s mood was perfectly in step with the song’s lyrics. “He had so much fun,” says Kevin’s mom, Laura. “He said he can’t wait to get on stage again.” While a first dance recital is a big deal for any 5-year-old, it’s especially poignant for Kevin, who was diagn...
Source: Thrive, Children's Hospital Boston - September 6, 2017 Category: Pediatrics Authors: Ellen Greenlaw Tags: Diseases & Conditions Our Patients’ Stories Dr. Pedro del Nido Dr. Wayne Tworetsky Ebstein's anomaly Fetal Cardiology Program 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

Nonagenarians'Good Candidates' for TAVI Surgery Nonagenarians'Good Candidates' for TAVI Surgery
Severe aortic-stenosis patients aged 90 years or older can be candidates for transcatheter aortic-valve implantation, with similar outcomes to those in younger patients, researchers say.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 1, 2017 Category: Consumer Health News Tags: Cardiology News 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

Eleven-Year-Old Boy Receives Kidney for Christmas at Duke
Treatment TermsPediatric Kidney Transplant Author Hallie Potocki Overview After battling kidney disease his entire young life, 11-year-old Kaleek Beatty got the best present he could ask for, just five days before Christmas 2016. Duke Children's Hospital called to say they had found a kidney for him. Hero Imagekaleekbeatty_blog.jpg Preview Image Content Blocks Header Born with Kidney Disease ContentAsk a typical 11-year-old, “What do you want to be when you grow up?” and you’re likely to hear “sports superstar” or “rock musician.” Ask Kaleek Beatty, though, and his u...
Source: dukehealth.org: Duke Health News - August 24, 2017 Category: Consumer Health News Authors: mf205 at duke.edu 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

PodMed: A Medical News Roundup From Johns Hopkins (with audio)
(MedPage Today) -- This week's topics include complications of aortic valve surgery, effectiveness of nasal flu vaccination (Source: MedPage Today Pulmonary)
Source: MedPage Today Pulmonary - August 12, 2017 Category: Respiratory Medicine Source Type: news

Aortic Annulus Rupture After TAVR:'Watch and Wait '
(MedPage Today) -- Injuries from Sapien valve implantation seem to follow a benign course (Source: MedPage Today Surgery)
Source: MedPage Today Surgery - August 9, 2017 Category: Surgery Source Type: news

Abbott launches trial of transcatheter tricuspid repair device, eyes CE Mark
Abbott (NYSE:ABT) said today it enrolled the 1st patient in a clinical trial of a minimally invasive, clip-based transcatheter valve repair system for treating patients with severe tricuspid regurgitation, looking to eventually support CE Mark approval in the European Union. The 1st patient in the trial was enrolled at the Abbott Northwestern Hospital by Dr. Paul Sorajja of the Minneapolis Heart Institute, the Abbot Park, Ill.-based company said. The transcatheter tricuspid valve repair system is built off of technology which has been tested with the company’s MitraClip system, designed to treat mitral valv...
Source: Mass Device - August 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Source Type: news

Abbott Leads Way in First Clinical Trial of Minimally Invasive Clip-based Repair System for Leaky Tricuspid Heart Valves
-Trial will study efficacy and safety of a new transcatheter clip-based repair system for tricuspid valve disease, an undertreated, life-altering condition (Source: Abbott.com)
Source: Abbott.com - August 9, 2017 Category: Pharmaceuticals Source Type: news

UCLA Health hospitals place No. 1 in Los Angeles, No. 7 nationally in prominent ranking
UCLA Health hospitals in Westwood and Santa Monica placed No. 1 in Los Angeles, No. 2 in California and No. 7 in the nation in the 2017 –18 U.S. News and World Report rankings.“UCLA Health is proud to be recognized for providing world-class treatment to patients from greater Los Angeles, across the state and around the globe,” said Johnese Spisso, president ofUCLA Health, CEO of UCLA Hospital System and associate vice chancellor of UCLA Health Sciences. “Our long-standing commitment to excellence ensures that our patients and their families receive the most compassionate, comprehensive care possible...
Source: UCLA Newsroom: Health Sciences - August 8, 2017 Category: Universities & Medical Training Source Type: news

FDA updates on Getinge/Datascope IABP recall, labels as Class I
The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The recall affects approximately 9,194 units in the US with model numbers CS100i, CSO100 and CS300, including all lot numbers manufactured before June 30, 2013 and distributed...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Recalls Datascope Corp. Getinge Maquet Cardiovascular LLC Source Type: news

LivaNova wins CMS NTAP reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless aortic heart valve replacement won approval from the Centers for Medicare and Medicaid Services for a New Technology Add-On Payment. The London-based company said that the Perceval valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technologies. With the reimbursement approval, CMS will begin to reimburse hospitals for the Perceval valve procedure with the normal Medicare Severeity Diagnosis Related Group payment as well as an additional $6,110.23, LivaNova said. “We are pleased ...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) LivaNova Source Type: news

UPDATE: CMS passes NTAP reimbursement for LivaNova ’ s Perceval, Edwards Intuity aortic valves
Updated to include that the CMS NTAP also covered Edwards Lifescience’s Intuity suturless aortic valve The Centers for Medicare and Medicaid Services today released its Final Rule for FY2018 Medicare Inpatient Payment and Policy, granting New Technology Add-On Payment reimbursement for rapid deployment valves, including LivaNova‘s (NSDQ:LIVN) Perceval and Edwards Lifesciences‘s (NYSE:EW) Intuity aortic valves. London-based LivaNova said that the Perceval sutureless valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technol...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Edwards Lifesciences LivaNova Source Type: news

Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart  said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device. Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage. The TriGuard 3 is designed to be anatomy independent and fo...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news

Medtronic wins FDA nod, CE Mark for Avalus aortic valve
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union and FDA approval in the US for its Avalus pericardial aortic surgical valve designed to treat aortic valve disease. The Avalus is the Fridley, Minn.-based company’s next-gen pericardial surgical aortic valve, and features a supra-annular design to improve hemodynamic performance and limit central regurgitation. The valve also features interior-mounted leaflet and frame design for improved durability and a low-profile design with a streamlined valve holder and single, one-cut release for easier implantations, Medtronic said. “Medt...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

TAVR, 15 Years Down: Shooting for the Moon, Reaching the Stars TAVR, 15 Years Down: Shooting for the Moon, Reaching the Stars
It's been 15 years since the first first transcatheter aortic valve replacement. How has this revolutionary procedure altered the landscape of cardiovascular medicine?Journal of the American College of Cardiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 31, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Toronto baby boy born healthy after surgery in the WOMB
On May 23, Sebastian was born pink and screaming in Toronto's Mount Sinai Hospital - days after undergoing groundbreaking surgery on his heart valves while he was still in the womb. (Source: the Mail online | Health)
Source: the Mail online | Health - July 26, 2017 Category: Consumer Health News Source Type: news

TMVR dev 4C Medical raises $9m
Structural heart disease device maker 4C Medical said today it completed a private placement of unsecured convertible promissory notes, raising approximately $9 million to help support development of its transcatheter tech designed to treat mitral regurgitation. The financing was led by Canadian angel network Anges Québec, the Brooklyn Park, Minn.-based company said. “We are excited to invest in 4C Medical. With a proven leadership team and a truly novel TMVR technology that eliminates the issues seen with current TMVR technologies, 4C Medical has the potential to addresses a significant unmet need,” Ang...
Source: Mass Device - July 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters 4cmedical Source Type: news

Bleeding Common Years After TAVR, and Deadly Bleeding Common Years After TAVR, and Deadly
Registry findings highlight an underappreciated risk after transcatheter aortic valve replacement -- late nonaccess site bleeding -- and the pressing need to fine-tune postprocedure anticoagulant and antiplatelet therapy.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 20, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Nathaniel ’s heart: One for the record books
As 3-year-old Nathaniel Wesley nervously watched the big machine move toward his chest, he spotted a familiar face: It was the cartoon character Barney — in sticker form. “Give Barney a kiss!” his parents urged, and he smiled at the friendly purple dinosaur while the scanner took images of blood flow in his lungs. Now 11, Nathaniel is no stranger to doctors, nurses or hospitals. Born with tetralogy of Fallot with pulmonary atresia — a severe congenital heart defect — he’s been a frequent visitor to the Heart Center at Boston Children’s Hospital for the past eight years. In this dis...
Source: Thrive, Children's Hospital Boston - July 19, 2017 Category: Pediatrics Authors: Jessica Cerretani Tags: Diseases & Conditions Our Patients’ Stories Cardiac Neurodevelopmental Program Dr. David Brown Dr. Janice Ware Dr. John Mayer Dr. Naomi Gauthier Heart Center tetralogy of Fallot with pulmonary atresia Source Type: news

Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22. Claret Medical is still looking to raise an additional $6.5 million in the round, according to the SEC filing. The company has not yet stated how it intends to use funds raised in the round. The Santa Rosa, Calif.-based company produces the Sentinel embolic protection device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel device uses a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Is this the key to rapidly manufacturing heart valves?
[Image from Wyss Institute at Harvard University]Nanofiber fabrication may be the key to rapidly manufacturing heart valves with regenerative and growth potential, according to new research from Harvard University’s Wyss Institute for Biologically Inspired Engineering. A research team led by Kevin Kit Parker created a valve-shaped nanofiber network that replicates the mechanical and chemical properties of the native valve extracellular matrix (ECM). They used the Parker lab’s proprietary rotary jet spinning technology that was essentially a rotating nozzle that thrust an ECM solution into the nanofibers. T...
Source: Mass Device - July 13, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Prosthetics Replacement Heart Valves Research & Development Harvard University MedTech Wyss Institute for Biologically Inspired Engineering Source Type: news

Study: TAVR, surgical AVR results similar at 2 years in intermediate risk patients
Transcatheter and surgical aortic valve procedures were shown to have similar outcomes at 2 years in severe aortic stenosis patients deemed to be at intermediate surgical risk, according to a recently published study. Data came from a 2-year follow up with patients in the Partner 2 trial, which aimed to explore the difference between the 2 procedures in intermediate risk patients. A total of 2,032 patients were examined in the trial, which was randomly divided into 2 cohorts, with the 1st receiving Edwards Lifesciences‘(NYSE:EW) Sapien XT and the 2nd receiving a surgical AVR procedure. At 2 years, both disease-s...
Source: Mass Device - July 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Innovative Cardiovascular Solutions raises $5m in oversubscribed Series B
Innovative Cardiovascular Solutions said today it raised $5 million in an oversubscribed Series B round of financing to support its Emblok embolic protection system. The Emblok system is an embolic protection device designed for full circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from embolic debris. The system is designed for use in transcatheter aortic valve replacement and structural heart procedures, theKalamazoo, Mich.-based company said. The system includes an integrated 4 French radiopaque pigtail catheter to provide constant visualization and eliminate the need...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Innovative Cardiovascular Solutions Source Type: news

FDA Gives Approval to Medtronic's CoreValve for Use in Patients at Intermediate Risk for Surgical Valve Replacement
Based on results from the landmark SURTAVI Clinical Trial, presented at the American College of Cardiology Annual Meeting in March, and published in the New England Journal of Medicine, the FDA has approved the CoreValve TAVR self-expanding platform for use in patients with severe and symptomatic aortic stenosis who are at "intermediate" risk for surgical valve replacement, defined as mortality>= 3% at 30 days. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 10, 2017 Category: Cardiology Source Type: news

FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery. The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure. “Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreV...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Finn ’s heart: A journey into the unknown
Three-year-old Finn stands in front of the full-length mirror in his parents’ room, with his shirt off. “Mommy, look how cool!” he shouts, placing his finger along the long scar running down the middle of his chest. “That’s where I had my heart surgeries!” “That’s right, buddy,” Jenna replies, surprised because they’d never talked about his scars. “We always tell him he has a special heart. We don’t ever want him to feel different.” Finn runs off to play. It makes Jenna smile and sometimes cry to see her son so happy and full of life. Now 5 years...
Source: Thrive, Children's Hospital Boston - July 7, 2017 Category: Pediatrics Authors: Jenny Fernandez Tags: Diseases & Conditions Our Patients’ Stories Christopher Baird complex congenital heart defect Heart Center hypoplastic left heart syndrome Wayne Tworetzky Source Type: news

Edwards Lifesciences wins FDA approval for Inspiris Resilia valve
Edwards Lifesciences (NYSE:EW) said today that it won pre-market approval from the FDA for its Inspiris Resilia surgical aortic valve replacement, claiming it as “the first in a new class of resilient heart valves.” Irvine, Calif.-based Edwards said the valve uses its Resilia tissue technology, which is designed to inhibit calcification and improve hemodynamic performance and dry storage. The company also touted Inspiris Resilia’s VFit expandable frame, which features size markers for later valve-in-valve procedures, and the underlying Carpentier-Edwards Perimount valve design. Edwards said it&r...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

UCLA team performs emergency surgery to save mom and newborn baby
UCLA Health When mom-to-be Malisa was just a few weeks away from delivering her first child, she felt a sudden pain in her chest while at the movies with a friend.Her doctors ruled out any problems with the pregnancy but did learn she had a rare, life-threatening heart condition called an aortic dissection, a tear in the aorta located just above the aortic valve involving the arteries that take blood to the heart and brain. The condition often leads to sudden death, but with unusual luck she was able to survive.Once diagnosed, Malisa, who lives about 80 miles from Los Angeles, was airlifted to  Ronald Reagan UCLA...
Source: UCLA Newsroom: Health Sciences - June 30, 2017 Category: Universities & Medical Training Source Type: news

Northwestern, University of Calgary win $3m grant for cardiac valve imaging project
Patients who are born with a bicuspid aortic valve have 2 flaps in their cardiac valve instead of 3 – and researchers from Northwestern University and the University of Calgary are planning a 5-year study to evaluate an imaging approach for preventing the complications of this genetic condition. With a $3.3 million grant from the National Institutes of Health, the team plans to use 4D-Flow MRI to visualize 3D blood flow in real time and analyze tissue to develop a personalized treatment for patients with BAV. “Not all BAV patients are the same, yet they are currently treated the same when it comes to timing and...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Imaging National Institutes of Health (NIH) Northwestern University universityofcalgary Source Type: news

How to regenerate a regenerative company: Admedus CEO Paterson on the company ’ s turnaround efforts
For over a year, Admedus (ASX:AHZ) has been engaged in a significant restructuring effort as it looks to break trends of overspending and edge towards profitability. The company is finally seeing fruits of its labors, posting its 1st cashflow neutral quarter this year and looking to a hopeful turn to profitability in the future. To lead the restructuring effort, the company turned to 25-year pharmaceutical vet Wayne Paterson, who told MassDevice.com in an interview that he’s been able to contribute a unique global perspective to the company, along with a wealth of experience in steering companies in the medical ...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Admedus Ltd. Source Type: news

Looking to the Future of Mitral Valve Replacement Looking to the Future of Mitral Valve Replacement
Is transapical transcatheter mitral valve implantation poised to become an alternative solution for patients with mitral valve disease?European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 30, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

HonorHealth cardiologist testing valve to replace open heart surgery
A team at HonorHealth has implanted a mitral valve in an elderly patient — while her heart was still beating. Until now, replacing a mitral valve required open heart surgery, which also requires that surgeons stop the patient's heart to perform the procedure, said Dr. David Rizik, chief scientific officer and director of structural intervention for HonorHealth in Scot tsdale. Rizik is the principal investigator for a feasibility study for Roseville, Minneapolis-based Tendyne Holdings Inc., maker… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 20, 2017 Category: Pharmaceuticals Authors: Angela Gonzales Source Type: news

HonorHealth cardiologist testing valve to replace open heart surgery
A team at HonorHealth has implanted a mitral valve in an elderly patient — while her heart was still beating. Until now, replacing a mitral valve required open heart surgery, which also requires that surgeons stop the patient's heart to perform the procedure, said Dr. David Rizik, chief scientific officer and director of structural intervention for HonorHealth in Scot tsdale. Rizik is the principal investigator for a feasibility study for Roseville, Minneapolis-based Tendyne Holdings Inc., maker… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 20, 2017 Category: Biotechnology Authors: Angela Gonzales Source Type: news

Getinge ’ s Maquet, Datascope recall select IABPs over electrical issues
The FDA today released information on a select voluntary recall from Getinge‘s (PINK:GETI B) Datascope and Maquet of its System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures. Datascope said they received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a CS300 IABP device which failed to pump due to electrical test failure code #58, a maintenance code and an autofill failure, according to the FDA notice. The company said the electrical test failure code was caused by a solenoid valve requ...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Recalls Getinge Maquet Cardiovascular LLC Source Type: news