LivaNova launches Chinese Perceval trial
LivaNova (NSDQ:LIVN) said today it launched a new trial of its Perceval sutureless aortic valve implant in China as it pursues Chinese Registration of the device. The 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. “We greatly look forward to the possibility of making this innovative technology, which has demonstrated excellent outcomes ...
Source: Mass Device - March 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves LivaNova Source Type: news
Edwards Eyes Delay for its Sapien 3 Ultra TAVR
Edwards Lifesciences said it is delaying the launch of the Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System in Europe until later this year. The Irvine, CA-based company said it would refocus on commercialization efforts after it submits data from the 30-patient, single-arm study of the device treating patients at intermediate risk from surgical valve replacement. The study data would help supplement the company’s bid to gain CE mark for the technology. Edwards said the updated timing for the European launch of the Sapien 3 Ultra doesn’t change the company’s sales guidance for 2018...
Source: MDDI - March 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news
Edwards Lifesciences delays Sapien 3 Ultra debut in Europe until later this year
Edwards Lifesciences (NYSE:EW) said yesterday that it’s hoping to launch its Sapien 3 Ultra replacement heart valve in Europe this year, after it submits data from a small, single-arm study of the device. Last fall, when it introduced its latest transcatheter aortic valve replacement, Edwards said it expected to win CE Mark approval by the end of 2017. Sapien 3 Ultra’s updates include a taller outer skirt and an “on-balloon” delivery design, the Irvine, Calif.-based company said at the time. The timeline for the Sapien 3 Ultra device was pushed back until “later in 2018,&rd...
Source: Mass Device - March 22, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Edwards Lifesciences Source Type: news
University Hospitals team performs first transcatheter mitral valve replacement in Ohio
(University Hospitals Cleveland Medical Center) University Hospitals Harrington Heart& Vascular Institute officially opened the APOLLO trial today implanting the Intrepid transcatheter mitral valve replacement system on the first patient involved in the study. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 22, 2018 Category: International Medicine & Public Health Source Type: news
New 3D Aorta Models Help Guide Heart Surgery
Surgeons are working on making heart valve replacement surgery safer for older patients by creating 3D-printed models of their aortas. ... Also of Interest Do you know these five heart attack risks? (Source: AARP.org News)
Source: AARP.org News - March 21, 2018 Category: American Health Source Type: news
Colibri Course Corrects to be Relevant in TAVR
Colibri Heart Valve LLC has started a feasibility study of its second-generation transcatheter aortic valve replacement system that will treat patients with severe aortic stenosis. The Broomfield, CO-based company said it has treated two patients in the study with its redesigned valve. “We spent the last three years modifying our product because the market has changed so drastically from 2012, in both patient indications and also bicuspid valves,” Joseph Horn, president and CEO of Colibri Heart Valve, told MD+DI. “We decided that the product we had was probably not going to be robust enough to satisfy the...
Source: MDDI - March 19, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Implants Source Type: news
Abbott wins Japanese reimbursement nod for MitraClip
Abbott (NYSE:ABT) said today that it logged a reimbursement win in Japan for its MitraClip device for treating mitral valve regurgitation. The Chicago-area medtech giant said Japan’s Ministry of Health, Labor & Welfare granted national reimbursement for MitraClip, effective April 1. The MHLW approved the device last November for treating severe degenerative mitral regurgitation functional mitral regurgitation. “Our mission is to develop technologies and therapies that help people return to better health and quality-of-life as quickly as possible,” structural heart VP Michael Dale said in pre...
Source: Mass Device - March 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Replacement Heart Valves Abbott Reimbursement Source Type: news
Cognitive Outcomes After TAVI Cognitive Outcomes After TAVI
Neurological injury is a common complication after cardiac surgery and may contribute to cognitive decline. Is transcatheter aortic valve implantation detrimental to cognition?Journal of the American Geriatrics Society (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 14, 2018 Category: Consumer Health News Tags: Family Medicine/Primary Care Journal Article Source Type: news
Medtronic and Edwards Duel in TAVR Space
A pair of studies support the long-term use of Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system. The Dublin-based company unveiled results from both the Nordic Aortic Valve Intervention Trial (NOTION) and the CoreValve U.S. Pivotal Extreme Risk Study at the American College of Cardiology 67th Annual Scientific Session (ACC) this past weekend. NOTION is a physician-initiated trial that studied an all-comers population of 280 patients at least 70 years old. Patients in the trial were randomized to either Surgical Aortic Valve Replacement (SAVR) or TAVR procedures. Join us at the BIOM...
Source: MDDI - March 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
Magistrate judge recommends dismissal of inventor doc ’ s suit against Abbott ’ s St. Jude Medical
A federal magistrate judge in Texas last week recommended dismissal for a lawsuit brought by a physician inventor against Abbott (NYSE:ABT) subsidiarySt. Jude Medical over transcatheter valve replacement technology. Dr. Robert Snyder, founder of Snyders Heart Valve, filed suits two years ago in the U.S. District Court for Eastern Texas, claiming that both St. Jude and cross-town rival Medtronic (NYSE:MDT) used technologies covered by his patents for an artificial heart valve and delivery system called the Funnel valve, according to court documents. The lawsuits, which were later consolidated for pre-tri...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Patent Infringement Replacement Heart Valves Medtronic stjudemedical Source Type: news
Transcatheter aortic valve replacement dramatically improves heart patients' quality of life
(Intermountain Medical Center) Patients who undergo a transcatheter aortic valve replacement, or TAVR -- a minimally-invasive surgical procedure that repairs a damaged heart valve -- experienced a significant increase in their quality of life, according to a new study by researchers at the Intermountain Medical Center Heart Institute in Salt Lake City. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 11, 2018 Category: International Medicine & Public Health Source Type: news
Abbott Proves That Size Does Matter
Abbott churned out an impressive number of new products last year, and our 2017 Medtech Company of the Year doesn't appear to be slowing down any. This week FDA approved Abbott's new pediatric mechanical heart valve, which is the first device of its kind that is small enough to be used in newborns and infants. Learn about the latest trends in medical device R&D and product development at BIOMEDevice Boston, April 18-19, 2018. Use promo code "MDDI" for 20% off conference registration and free expo access. Previously, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve, Abb...
Source: MDDI - March 8, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news
3D Technology Helps Personalize Aortic-valve Replacement 3D Technology Helps Personalize Aortic-valve Replacement
Cardiologists and biomechanical engineers at The Ohio State University Wexner Medical Center are using 3D technology to determine the best heart-valve replacement option for patients before surgery to avoid postoperative complications such as leaks, obstructions and blood clots.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - March 7, 2018 Category: Surgery Tags: Cardiology News Source Type: news
Abbott wins FDA nod for pediatric Masters Series mechanical heart valve
Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world. The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position and consists of two semi-circular discs that open and close in response to blood pressure changes during the heart beat, according to an FDA release. The newly approved 15mm version of the device clears the valve for use in pediatric pat...
Source: Mass Device - March 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Abbott stjudemedical Source Type: news
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world. Size is small enough to be used in newborn pediatric patients to treat heart defects https://go.usa.gov/xnutA #MedicalDevicepic.twitter.com/ec0qp5qotN
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world. Size is small enough to be used in newborn pediatric patients to treat heart defects https://go.usa.gov/xnutA #MedicalDevice pic.twitter.com/ec0qp5qotN (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 6, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
(Source: Food and Drug Administration)
Source: Food and Drug Administration - March 6, 2018 Category: American Health Source Type: news
Edwards Lifesciences eyes Ireland for 600-worker plant
Edwards Lifesciences (NYSE:EW) is reportedly planning to build a plant in Ireland that could employ as many as 600 workers by 2020. The $98.5 million (€80 million) facility in the Emerald Isle’s Mid-West region will produce the delivery systems for replacement heart valves, according to the Independent. Edwards initially plans to hire about 60 people beginning in June who will work at a temporary site in Shannon, the newspaper reported. “The addition of a manufacturing location in Ireland is an element of Edwards’ global supply strategy to support future growth and reliability of supply, an...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Edwards Lifesciences Source Type: news
Terumo pays at least $20m for Medeon Biodesign ’ s XPro vascular closure device
Medeon Biodesign (TPEx:6499) said today that it agreed to sell its XPro suture-mediated vascular closure device to Terumo Corp. (TYO:4543) for $20 million up front, plus milestones. The XPro device is designed for vascular closure following transcatheter aortic valve replacement, endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon aortic valvuloplasty procedures. Medeon said it plans to continue working with Terumo on future technical, clinical and regulatory developments for the system. In May 2017 Medeon won approval in New Zealand for a clinical trial of the XPro s...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Vascular Wall Street Beat Medeon Biodesign Terumo Source Type: news
Engineers, physicians, team to replace heart valves using personalized modeling
(MediaSource) Engineers are exploring applications for 3-D printers in the medical field, and the newest research is now going from the lab to the operating room. Experts at The Ohio State University Wexner Medical Center use CT scans to model a patient's aorta, then create a 3D-printed replica down to its exact texture based on the calcification in a patient's tissue. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - March 5, 2018 Category: International Medicine & Public Health Source Type: news
Mitral Valve Prolapse (Syndrome, Symptoms, Causes, Treatment, Surgery)
Title: Mitral Valve Prolapse (Syndrome, Symptoms, Causes, Treatment, Surgery)Category: Diseases and ConditionsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 3/2/2018 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - March 2, 2018 Category: Cardiology Source Type: news
OHSU performs first mitral valve replacement in state without open heart surgery
On Feb. 7, OHSU became the third institution nationally to perform transcatheter mitral valve replacement as part of a new clinical trial. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 1, 2018 Category: Pharmaceuticals Authors: Elizabeth Hayes Source Type: news
LivaNova shares up on topped Q4, 2017 earnings
Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker met most of the expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings results. The London-based company posted losses of $111.7 million, or $2.32 per share, on sales of $278.4 million for the 3 months ended December 31, seeing losses grow 61.5% while sales grew 11.5% compared with the same period during the previous year. After adjusting to exclude one-time items, earnings per share were 89¢, just ahead of the 77¢ consensus on Wall Street where analysts were expecting to see sales of $262.7 million. For ...
Source: Mass Device - February 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news
Edwards Lifesciences recalls Cardioband anchors
Edwards Lifesciences (NYSE:EW) last month recalled the anchors used with its Cardioband mitral valve repair device after receiving a pair of reports that the device came loose from the surrounding tissue. The Cardioband device, acquired in the $690 million buyout of Valtech Cardio last year, is designed to reshape the mitral valve using specially designed anchors. In a letter to physicians posted by German regulators Jan. 26, Edwards said a manufacturing tweak, although within its specs, was responsible for the issue. “Through the review of recent case reports, we have noted an increased number and rat...
Source: Mass Device - February 28, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Recalls Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Tricuspid repair firm 4Tech taps ex-Boston Scientific execs for CEO, CMO | Personnel Moves for Feb. 27, 2018
4Tech said last week that it named a pair of BSX veterans as its new CEO and CMO, with onetime chief Mike Ennen stepping away for “family reasons.” Galway, Ireland-based 4Tech said former Boston transcatheter aortic valve GM Tom Fleming is slated to take the reins from Thoratec vet Ennen as president & CEO in March. The company, which is developing the TriClinch Coil transcatheter tricuspid valve repair device, also said that Dr. Keith Dawkins, Boston’s ex-global medical chief, was named CMO effective Feb. 22. Z-Medica lures ex-Hologic COO Compton Z-Medica said it named former Hol...
Source: Mass Device - February 27, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Wall Street Beat 4Tech Check-Cap CHF Solutions Inc. imaginmedical imagionbiosystems Invacare LimFlow orthosalespartners personnel-moves Teleflex Source Type: news
Less-invasive heart valve replacement tied to better quality of life
(Reuters Health) - People who get minimally-invasive surgery to replace damaged heart valves have an easier time completing daily tasks and a better quality of life after the procedure, a research review suggests. (Source: Reuters: Health)
Source: Reuters: Health - February 23, 2018 Category: Consumer Health News Tags: healthNews Source Type: news
NaviGate touts implantation for Gate transcath tricuspid valve replacement
NaviGate Cardiac Structures Inc. said today that earlier this month, its catheter-guided Gate valved-stent bioprosthesis became the first orthotopic valve replacement in Canada to treat severe tricuspid regurgitation. The implantation was done at the Quebec Heart and Lung Institute, lead by interventional cardiologists Dr. Josep Rodes-Cabau and Dr. Francois Dagenais. The 79-year-old male patient who received the implant had severe symptomatic tricuspid regurgitation and was not eligible for standard cardiac surgery, according to NaviGate. “The NaviGate bioprosthesis is the only transcatheter device in development tha...
Source: Mass Device - February 22, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Replacement Heart Valves NaviGate Cardiac Structures Inc Source Type: news
Boston Sci Employee Found Guilty in Criminal Case
Boston Scientific faces $1 million in fines after an Italian court found one of its employees guilty in a criminal case, according to an SEC filing. On Feb. 23, 2015, the judge for the Court of Modena (Italy) ordered a trial for the Marlborough, MA-based company and three of its employees as well as numerous other defendants charged in criminal proceedings. Those charges arise from allegations that the defendants made improper donations to certain healthcare providers and other employees of the Hospital of Modena in order to induce them to conduct unauthorized clinical trials, as well as related government fraud in relatio...
Source: MDDI - February 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news
Mitralign raises $10m
Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million. The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016. The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Mitralign Inc. Source Type: news
Edwards Adds Bold New Chapter to TAVR Story
Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM&...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Medical Device Business Source Type: news
Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-ex...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Why Pig Organs Could Be the Future of Transplants
Making human tissue in a lab has always been more sci-fi than sci-fact, but powerful genetic technologies may change that soon. For the most part, the only way to replace diseased or failing hearts, lungs, kidneys and livers is with donor organs. Even then, many people struggle to find a good biological match with a donor, and 8,000 die each year in the U.S. while waiting for an organ. In one promising solution to the shortage, researchers have been putting a new DNA editing tool called CRISPR through rigorous tests in organ regeneration. Last August, a group of scientists led by George Church, professor of genetics at Har...
Source: TIME: Health - February 15, 2018 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthytime Longevity organ transplants Source Type: news
ASK THE GP: Do I need surgery for my leaky heart valve?
The Daily Mail's resident GP answers your queries on everything and anything. This week, leaky heart valves and dis-coloured tongues. (Source: the Mail online | Health)
Source: the Mail online | Health - February 12, 2018 Category: Consumer Health News Source Type: news
Tax revision pushes Edwards Lifesciences into Q4 red
Edwards Lifesciences (NYSE:EW) revised its books based on new tax rules on repatriating foreign profits that went into effect last year, leading to a swing to losses for the fourth quarter and modest growth for the full year. The charges, amounting to a $326.7 million Q4 charge and $451.3 million for 2017, left the replacement heart valve maker’s sales and adjusted earnings untouched. Edwards had reported the charges as $288.2 million and $412.8 million, respectively. The Irvine, Calif.-based company originally posted Q4 profits of $35.7 million, or 17¢ per share, on sales of $888.5 million, for a...
Source: Mass Device - February 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Replacement Heart Valves Wall Street Beat Edwards Lifesciences Source Type: news
Depression Ups Mortality Risk Post Aortic Valve Replacement
Three - fold increase in mortality at 12 months among older individuals with persistent depression (Source: The Doctors Lounge - Psychiatry)
Source: The Doctors Lounge - Psychiatry - February 3, 2018 Category: Psychiatry Tags: Cardiology, Psychiatry, Surgery, Critical Care, Journal, Source Type: news
Wait Continues for Boston Scientific & #039;s Lotus Edge
Boston Scientific confirmed it will keep its Lotus Edge transcatheter aortic valve replacement (TAVR) device off the market in Europe until 2019. The Marlborough, MA-based company addressed the beleaguered product’s future during its fourth-quarter 2017 earnings call earlier this week. The company initially secured CE mark for the Lotus Edge valves in September 2016 but has yet to gain FDA approval for the device. “Regarding our Lotus Edge TAVR valve platform … our goal is to launch Lotus Edge in the U.S. and European markets in 2019,” Mike Mahoney, president and CEO of Boston Scientific,...
Source: MDDI - February 2, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news
Boston Scientific confirms Lotus valve off the market until 2019
Boston Scientific (NYSE:BSX) CEO Mike Mahoney yesterday confirmed that the company’s entry into the transcatheter aortic valve market, Lotus, will remain off the market for the rest of the year. Last November news of another Lotus delay pared $3 billion from Boston’s market capitalization. The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February 2017 over issues with its locking mechanism, said it no longer expected the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow th...
Source: Mass Device - February 2, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Wall Street Beat Boston Scientific Source Type: news
Neovasc wins German reimbursement for Reducer system
Neovasc (NSDQ:NVCN) said today that it won reimbursement coverage from the German Institute for the Hospital Renumberation System for its Reducer device designed to treat refractory angina. The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous procedure, Neovasc said. The German body gave the device Nub status 1 designation for 2018, the highest priority designation available, up from a previously set Nub 4 status, the Vancouver-based company said....
Source: Mass Device - February 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Neovasc Inc. Source Type: news
Boston Scientific Seizes an Opportunity in Mitral Valve Repair
Boston Scientific may be gearing up to make an acquisition in the mitral valve repair space sometime in the next year or two. The Marlborough, MA-based company purchased $90 million worth of stock in Millipede, a Santa Ana, CA-based company that has developed the Iris transcatheter annuloplasty ring system for the treatment of severe mitral regurgitation (MR). The two companies also reached an agreement giving Boston Scientific the option to acquire Millipede at any time prior to the completion of a first-in-human study that meets certain parameters. After the study, Millipede has the option to compel Boston Scientific to ...
Source: MDDI - January 24, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Medical Device Business Source Type: news
Boston Scientific puts $90m into Millepede
Boston Scientific (NYSE:BSX) said today that it took out a $90 million position in Millepede that includes an option to buy the heart valve repair firm. Santa Rosa, Calif.-based Millipede makes the Iris transcatheter annuloplasty ring for treating mitral valve regurgitation. Marlborough, Mass.-based Boston Scientific can trigger the option to acquire the rest of Millipede any time before a first-in-human study of the device; completion of the study gives Millipede the right to trigger the full acquisition for $325 million, plus a $125 million commercial milestone. Both options are good until the end of next year....
Source: Mass Device - January 24, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Regulatory/Compliance Wall Street Beat Boston Scientific millipede Source Type: news
3 Medtech Markets That Are Showing Growth
Mike Matson, a medtech analyst at Needham & Co., kicked off earnings season with a recent report on three sectors he thinks grew last quarter, compared to the previous quarter, based on early earnings announcements from several companies. Matson noted that 12 of the firm's 21 covered companies preannounced fourth-quarter 2017 results, and all but one (NuVasive) beat consensus revenue estimates. Needham builds its market models with a bottom-up approach by using its estimates for companies the firm covers and consensus estimates for companies it does not cover. Cardiovascular Growth Trends Matson said he expects ca...
Source: MDDI - January 23, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Orthopedics Source Type: news
3 secrets of medtech success from a true industry pioneer
From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career. MDO’s executive editor Brad Perriello (left) interviews Stanton Rowe (right), chief scientific officer and corporate VP at Edwards Lifesciences, at DeviceTalks West, December 2017 in Orange County, Calif. “The impossible is the most fun you can have in medical device development,” Rowe said. Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him ...
Source: Mass Device - January 23, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Cardiac Implants Cardiovascular DeviceTalks Q&A Replacement Heart Valves Stents DeviceTalks West Edwards Lifesciences tavr Source Type: news
Depression Hurts Post-AVR Survival, So Screening, Treatment Urged Depression Hurts Post-AVR Survival, So Screening, Treatment Urged
The effect was especially pronounced when questionnaires indicated depression both before and 6 months after aortic valve replacement; some question whether the finding can be clinically useful.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - January 22, 2018 Category: Cardiology Tags: Cardiology News Source Type: news
Depression at Time of Aortic Valve Replacement Tied to Higher Mortality Risk
Older adults undergoing transcatheter or surgical aortic valve replacement (TAVR or SAVR) who are depressed face increased mortality risk in the year after the procedure... (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - January 18, 2018 Category: Primary Care Source Type: news
LivaNova launches post-market study of bioprosthetic aortic heart valves
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up. “Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news
Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve
Edwards Lifesciences (NYSE:EW) is recalling the Certitude delivery device used with its Sapien 3 replacement heart valve on the risk that a molding defect could embolize, the FDA said today. The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis. During implantation the valve is crimped to Certitude’s balloon before either transapical or transaortic insertion into the body. The recall, of some lots made between Nov. 22, 2016, and July 10 of last year, is due to a molding overflow defect in the button valve within Certitude’s loader, according to the federal safety watchd...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Recalls Replacement Heart Valves Edwards Lifesciences Source Type: news
Winning Senior Olympic Gold After Heart Surgery and Cardiac Rehab
Treatment TermsHeartCardiac prevention and cardiac rehabilitation Overview Dick Mazur of Raleigh was a fit 76-year-old planning to compete in the Senior Olympics for his third year in a row when his plans got waylaid. Diagnosed with a serious heart problem, he underwent heart surgery followed by cardiac rehab at Duke Health. Mazur went on to compete in the Senior Olympics after all, where he won three medals. “I owe it all to the rehab people,” he said. Hero Imagedickmazur_cardio_140.jpg Preview Image Content Blocks Header Dr. Rockman Makes a Game Plan, Assembles Heart Team ContentIt started one morning...
Source: dukehealth.org: Duke Health News - January 10, 2018 Category: Consumer Health News Authors: dg62 at duke.edu Source Type: news
3 Reasons TAVR Will Continue to Prosper
The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space. Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic...
Source: MDDI - January 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news
Neovasc ticks up on Tiara valve update
Neovasc (NSDQ:NVCN) today reported low leak rates in the clinical program for its Tiara mitral valve replacement and a 30-day all-cause mortality rate of nearly 10%. Vancouver-based Neovasc said 47 patients have been implanted with the Tiara transcatheter mitral valve replacement using a roughly 20-min. procedure, with 42 reaching the 30-day mark. The all-cause mortality rate at that point was 9.5%, the company said. “Technical success rates are very high, and typically result in the complete resolution of the patient’s MR; paravalvular leak levels are reported as absent, trace, or mild, in 100% of these c...
Source: Mass Device - January 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Neovasc Inc. Source Type: news
These lab-grown blood vessel replacements could benefit dialysis patients
[Image from University of Minnesota]University of Minnesota researchers have developed a blood vessel replacement made of biological materials in a lab. The lab-grown vessels have no living cells at implantation and could be used as a graft for kidney dialysis patients. The lab-engineered blood vessel replacement is the first nonsynthetic, decellularized graft that is repopulated with cells using the recipient’s cells when implanted. The grafts could also be used as coronary and peripheral bypass blood vessel and tubular heart valves. Approximately 480,000 people are on dialysis in the U.S., according to the National...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Implants Regenerative Medicine Research & Development kidney dialysis MedTech University of Minnesota Source Type: news
Improved Outcomes With Self-expanding TAVR System Improved Outcomes With Self-expanding TAVR System
The new CENTERA transcatheter aortic valve appears to be safe and effective, yielding low mortality, significantly improved hemodynamics, and a low rate of adverse events.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 28, 2017 Category: Surgery Tags: General Surgery News Source Type: news