Medical News Today: Heart surgery: Does it impact cognitive ability?
A new review looks at the impact of heart valve surgery on cognitive ability. A deficit may occur during the first few months, but more study is needed. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - October 17, 2018 Category: Consumer Health News Tags: Cardiovascular / Cardiology Source Type: news

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the T...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

Micro Interventional Devices begins study of tech for heart valve repair
The first patient in the transcatheter arm of a European study has been treated with Micro Interventional Devices’ MIA technology for tricuspid and mitral repair, the company said. A team at Vilnius University Hospital Santariskiu Clinic (Vilnius, Lithuania) used the 12F MIA (minimally invasive annuloplasty) delivery catheter and PolyCor anchors to reduce tricuspid annular dimensions and tricuspid regurgitation (TR) in the patient. The 61-year-old female was suffering from severe torrential tricuspid regurgitation. The physicians were able to reduce the dilated tricuspid annulus by 29%, from 20.9cm2 to 14.9...
Source: Mass Device - October 15, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Featured Research & Development Micro Interventional Devices Source Type: news

FDA clears Transseptal Solutions ’ TP Crosser transseptal access device
Medtech developer Transseptal Solutions said yesterday it won FDA 510(k) clearance for its TSP Crosser transseptal access system. The Israel-based company said that the TSP Crosser is an advanced transseptal puncture system which features a built-in steering mechanism and is designed for use in accessing the left atrium. The system is intended for use during procedures including mitral valve repair and replacement, paravalvular leak closure, left atrial appendage closure and EP ablation treatments. “Transseptal Solutions FDA clearance announcement is timely. There is a growing global demand for trans-septal catheter ...
Source: Mass Device - October 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance transseptalsolutions Source Type: news

Oct 12, 2018 This Week in Cardiology Oct 12, 2018 This Week in Cardiology
Timing of aortic valve replacement, rivaroxaban failure post TAVR, statins beyond CVD, conflicts of interest, and post-stent antithrombotic management are discussed in this week ’ s podcast.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 12, 2018 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

Does open heart surgery affect cognitive abilities?
(American Geriatrics Society) Understanding how heart valve surgery may affect your cognition is important for older adults. To learn more, researchers reviewed studies to see how patients' cognition changed before and after heart valve surgery. They also looked at whether surgeries on two types of heart valves, the mitral or the aortic, were associated with better or worse outcomes. Their study was published in the Journal of the American Geriatrics Society. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 12, 2018 Category: International Medicine & Public Health Source Type: news

Early AVR in Asymptomatic Severe Aortic Stenosis: New Support Early AVR in Asymptomatic Severe Aortic Stenosis: New Support
' We think it should be a class I recommendation'that such patients with certain echocardiographic risk markers be considered for surgical or transcatheter aortic valve replacement, said a researcher.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 10, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. 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 Edwards said. The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoin...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Teleflex Makes an ‘Essential’ Acquisition
Teleflex is making a move to expand its presence in the structural heart and endovascular aneurysm repair markets. To do this, the Wayne, PA-based company is acquiring Essential Medical for an undisclosed sum. Essential Medical has developed and received a CE mark for the MANTA Vascular Closure Device. The Exton, PA-based company’s device is designed for closure of large bore arteriotomies following procedures utilizing devices or sheaths ranging in size from 10F to 18F. Teleflex said MANTA is expected to receive FDA approval in 2019. “We are very excited to announce this acquisition, wh...
Source: MDDI - October 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Teleflex picks up Essential Medical and its Manta vascular closure device
Teleflex (NYSE:TFX) said yesterday that it acquired Essential Medical and its Manta vascular closure device for an unspecified amount. Manta is designed to close punctures at femoral arterial access sites after catheterization procedures, including transcatheter aortic valve replacements, endovascular treatment of abdominal aortic aneurysms, ventricular assist procedures and balloon aortic valvuloplasties. Exton, Pa.-based Essential won CE Mark approval in the European Union for Manta in July 2016 and is seeking pre-market approval from the FDA. The federal safety watchdog granted an investiga...
Source: Mass Device - October 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Vascular Wall Street Beat Essential Medical Devices Teleflex Source Type: news

Rebuilding young lives with cell-free heart valves
Various options exist for the replacement of failing heart valves. However, none of the conventional ones are particularly well suited to persons in their teens or twenties, say EU-funded researchers who have developed an innovative solution to boost such patients' chances of leading normal lives. (Source: EUROPA - Research Information Centre)
Source: EUROPA - Research Information Centre - September 28, 2018 Category: Research Source Type: news

Tiny device to 'zip up' leaky hearts invented by Dr Oz 20 years ago could save millions
A new minimally invasive approach to fixing faulty heart valves may offer hope to millions of Americans who couldn't risk open heart surgery, a new Columbia University study found. (Source: the Mail online | Health)
Source: the Mail online | Health - September 26, 2018 Category: Consumer Health News Source Type: news

New Device Offers Hope For People With Heart Failure
(CNN) — A tiny new device is offering hope of a better life for people with severe heart failure, reducing hospitalization rates and improving mortality risk within two years of treatment, a new study finds. Heart failure affects an estimated 5.7 million Americans and more than 26 million people globally, causing shortness of breath and tiredness among those affected as their heart struggles to pump blood around the body. One cause of severe heart failure that currently has a poor prognosis is a leaky valve, particularly the leakage of the mitral valve, which control’s blood flow in the left part of the heart....
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 26, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Heart Failure Local TV Source Type: news

This Medical Clip May Be a Powerful Treatment for Heart Failure, Study Says
A seemingly simple but sophisticated clip may usher in a “new era” for patients suffering from a severe and difficult-to-treat complication of heart failure, according to a new study. The device, called the MitraClip, reduced hospitalizations related to heart failure by nearly half and deaths by nearly 40% among patients with a specific and serious complication of heart failure, compared to those who received standard medical treatment. The results were published Sunday in the New England Journal of Medicine. “This therapy really offers an important new option for very desperate patients who are suffering...
Source: TIME: Health - September 24, 2018 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthytime Research Source Type: news

Tiny Device Is a ‘ Huge Advance ’ for Treatment of Severe Heart Failure
A clip used to repair damaged heart valves sharply reduced deaths among patients with a grim prognosis. (Source: NYT Health)
Source: NYT Health - September 23, 2018 Category: Consumer Health News Authors: GINA KOLATA Tags: Heart Surgery and Surgeons heart failure Source Type: news

Boston Scientific launches LithoVue Empower kidney stone retrieval device
Boston Scientific (NYSE:BSX) said today it launched its LithoVue Empower retrieval deployment device designed to be used with the LithoVue single-use digital flexible ureteroscope during ureteroscopic kidney stone retrieval procedures. The Marlborough, Mass.-based company said that the LithoVue Empower is intended to turn a two-person stone basketing procedure into a single-person procedure, allowing urologists to operate a ureteroscope and basket simultaneously during the procedure. The newly launched device is one of several new devices Boston Scientific said it plans to release to address “unmet needs an...
Source: Mass Device - September 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Urology Boston Scientific Source Type: news

Cardiovalve launches pivotal TMVR trials
Israel cardiovascular device developer Cardiovalve said yesterday it launched both the Ahead US and Ahead EU multicenter studies of its Cardiovalve transfemoral mitral valve replacement system. The company’s flagship Cardiovalve system is a novel mitral valve designed for either transferal or transeptal use and is intended to replace the mitral valve through a minimally invasive procedure. Cardiovalve touted that the device features a short profile for minimal protrusion to the left ventricle and minimized interference in cardiac blood flow. Cardiovalve said that will begin enrollment in the Ahead US trial early in t...
Source: Mass Device - September 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves cardiovalve Source Type: news

Medtech pioneer Rowe, Deerfield launch $275m medical device incubator
A medtech pioneer, Stanton Rowe, and investment firm Deerfield Management said today that they’re going in on a medical device incubator backed by $275 million from the investment firm, with Rowe as CEO. The Irvine, Calif.-based NXT Biomedical incubator plans to spend $25 million over the next five years on “cutting-edge technologies” designed to address unmet needs, with another $250 million pledged for creation of five to eight startups to be spun out of the incubator. And it’s “exploring potential collaborations with unnamed strategic partners,” according to Deerfi...
Source: Mass Device - September 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Funding Roundup Replacement Heart Valves Wall Street Beat NXT Biomedical Source Type: news

Cardiac Dimensions launches pivotal Carillon mitral repair device trial
Cardiac Dimensions said today it launched a pivotal trial of the Carillon mitral valve repair device it’s developing, and that it enrolled and randomized its first patient in the trial. The Kirkland, Wash.-based company’s percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device. The first patient in the trial was enrolled and ...
Source: Mass Device - September 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Cardiac Dimensions Source Type: news

Cardiac Dimensions launches pivotal trial for Carillon mitral repair device
Cardiac Dimensions said today it launched a pivotal trial of the Carillon mitral valve repair device it’s developing, and that it enrolled and randomized its first patient in the trial. The Kirkland, Wash.-based company’s percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device. The first patient in the trial was enrolled and ...
Source: Mass Device - September 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Cardiac Dimensions Source Type: news

Medtronic Will Study TAVR in Low-Risk Patients with Bicuspid Valves
Indication is to the transcatheter aortic valve replacement (TAVR) market as location is to the real estate business. Although TAVR already represents a $3 billion market globally, the leading TAVR companies say the currently approved indications barely scratches the surface in terms of the true growth potential of the space. This week, just ahead of the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Diego, Medtronic announced that FDA has given the go-ahead for a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of s...
Source: MDDI - September 18, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Medtronic launches study for bicuspid TAVR in low-risk patients
Medtronic (NYSE:MDT) said today that it’s launching a study of its CoreValve Evolut replacement heart valve in a low-risk patient population with a genetic form of heart disease, following a pair of FDA decisions about the treatment. The Fridley, Minn.-based medtech titan said the FDA granted an investigational device exemption for a single-arm trial of the CoreValve Evolut transcatheter aortic valve replacement in low-risk patients born with two leaflets instead of three. Separately, the federal safety watchdog revised the valve’s labeling to remove a warning about treatment of intermediate-or-greater-risk bic...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Food & Drug Administration (FDA) Replacement Heart Valves Medtronic Source Type: news

Where a Sore Throat Becomes a Death Sentence
Once a year, doctors travel to Rwanda to perform lifesaving surgery on people with damaged heart valves — a disease caused by untreated strep throat. (Source: NYT Health)
Source: NYT Health - September 16, 2018 Category: Consumer Health News Authors: DENISE GRADY Tags: Heart Strep Throat Rheumatic Fever rheumatic heart disease heart valves heart surgery Team Heart Cecilia Patton-Bolman Dr. R. Morton Bolman III Dr. Joseph Mucumbitsi Rwanda Kigali (Rwanda) Source Type: news

Boston Scientific touts Acurate Neo2 CE Mark study
Boston Scientific (NYSE:BSX) yesterday touted results from a European study of the Acurate Neo2 replacement heart valve it acquired along with Symetis last year. Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said. Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause ...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news

4C Medical raises $17m Series A for mitral repair device
4C Medical Technologies said today that it raised a $17 million Series A round for the AltaValve transcatheter mitral valve replacement device it’s developing. Brooklyn Park, Minn.-based 4C Medical, which drummed up a $9 million seed round in July 2017, said its latest private placement was led by an undisclosed “multi-national strategic investor” and included existing backers. The AltaValve TMVR is designed to preserve the native mitral valve and left ventricle by using supra-annular, atrial-only fixation. “The additional capital from our Series A financings significantly bolsters our abi...
Source: Mass Device - September 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Funding Roundup Replacement Heart Valves Wall Street Beat 4cmedical Source Type: news

Latest Structural Heart issue features research on TAVR and Mitral VIV and VIR procedures
(Cardiovascular Research Foundation) The Cardiovascular Research Foundation (CRF) is pleased to announce that the latest issue of Structural Heart: The Journal of the Heart Team features original research articles on transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis and left ventricular systolic dysfunction, and the safety and efficacy of percutaneous mitral valve-in-valve and valve-in ring procedures. The full issue is now available online. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 7, 2018 Category: International Medicine & Public Health Source Type: news

Gore Enhances Structural Heart Portfolio with Pipeline Deal
W. L. Gore & Associates is piping some money into a company that has been stealthily developing an entirely catheter-based repair procedure for patients with mitral valve disease. Flagstaff, AZ-based Gore has acquired Santa Rosa, CA-based Pipeline Medical Technologies for an undisclosed sum. Pipeline is developing a device designed to replicate the outcomes of a highly effective surgical procedure via a catheter, avoiding the trauma and many of the risks associated with open heart surgery. "Pipeline's cutting-edge repair procedure, for patients with mitral valve disease, has the potential to expand Gore's growing ...
Source: MDDI - September 6, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Cardiovascular Source Type: news

Gore picks up stealthy Pipeline Medical and its mitral repair program
W.L. Gore & Assoc. said today that it acquired stealthy Pipeline Medical Technologies and its mitral repair program for an undisclosed amount. Santa Rosa, Calif.-based Pipleline is developing a transcatheter device designed to duplicate the efficacy and outcomes found when mitral valve chords are repaired via open heart surgery. Gore said it plans to run the company as a wholly owned subsidiary under the Pipeline brand. “The addition of Pipeline’s investigational technology and talented associates bolsters our continued ambition to improve patients’ lives by offering physicians innovative treatme...
Source: Mass Device - September 6, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Mergers & Acquisitions Replacement Heart Valves Pipeline Medical Technologies W.L. Gore & Associates Source Type: news

Not Aall TAVR Valves the Same in Producing Embolic Debris Liam Davenport Not Aall TAVR Valves the Same in Producing Embolic Debris Liam Davenport
The type of valve used during a transfemoral aortic valve replacement affects the embolic debris produced, with balloon-expandable valves producing the largest particles, a new study suggests.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 29, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Not All TAVR Valves the Same in Producing Embolic Debris Not All TAVR Valves the Same in Producing Embolic Debris
The type of valve used during a transfemoral aortic valve replacement affects the embolic debris produced, with balloon-expandable valves producing the largest particles, a new study suggests.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 29, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Ross procedure may provide longer survival and better quality of life, study suggests
Compared to mechanical aortic valve replacement surgery, researchers find the largely unused Ross procedure may provide important benefits to adult patients (Source: St. Michael's Hospital News and Media)
Source: St. Michael's Hospital News and Media - August 27, 2018 Category: Hospital Management Tags: Hospital News Source Type: news

Medtronic CEO: Our Pipeline Has Never Been Stronger
Medtronic executives were upbeat about the company's fiscal first-quarter 2019 results Monday, and for good reason. The company beat analyst expectations on both earnings and revenue and offered a positive outlook for the back half of the year. "We are executing on the strongest pipeline in Medtronic’s nearly 70-year history," CEO Omar Ishrak said during the earnings call, as transcribed by SeekingAlpha. Later he reiterated that sentiment in response to an analyst's question, "Our pipeline has never been stronger." One area of interest, in particular, is the company's diabetes group, w...
Source: MDDI - August 21, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System. Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2. The TAH-t system is designed to function as a bridge to a heart transp...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news

Boston Scientific to submit last FDA PMA module for Lotus Edge aortic valve this month
Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week. The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years. Last November, Boston Scientific announced news of a delay that resulted in a $3 billion drop in its market capitalization. Earlier that year in February, the company recalled the Lotus TAVR system over issues with its locking mechanism and said it didn’t expect to be able to get the d...
Source: Mass Device - August 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Replacement Heart Valves Boston Scientific Source Type: news

LivaNova Looking to Be a Standout Firm in TMVR
LivaNova is getting closer to becoming a major player in the transcatheter mitral valve replacement (TMVR) space. The company, which was formed when Sorin Group and Cyberonics merged back in 2015, said it has concluded, PRELUDE, the U.S. feasibility study of its TMVR technology. With the conclusion of PRELUDE, the London-based company will now focus on enrolling patients into its INTERLUDE CE mark trial and finalize the protocol for, ENSEMBLE, the U.S. pivotal trial. PRELUDE is a first-in-human study that evaluates the Caisson TMVR system to treat moderate to severe mitral regurgitation, using a transseptal approach. This ...
Source: MDDI - August 6, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Post-TAVR ECG Indicates Risk of Later Conduction Disturbances
(MedPage Today) -- Abnormal findings linked to high-degree conduction defects within 30 days of transcathether aortic valve replacement (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 6, 2018 Category: Cardiology Source Type: news

LivaNova touts completion of 1st-in-man transseptal Caisson TMVR feasibility study
LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation. In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses a catheter inserted through an incision in the groin instead of an opening in the chest. LivaNova touted “positive patient outcomes” from the study, but has not released data from it. The company said that...
Source: Mass Device - August 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves LivaNova Source Type: news

Increase in Proportion of TAVR Used From 2012 to 2015
MONDAY, Aug. 6, 2018 -- From 2012 to 2015, there was an increase in the number of patients overall and age 65 years and younger receiving transcatheter aortic valve replacement (TAVR), according to a research letter published online July 23 in the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 6, 2018 Category: Pharmaceuticals Source Type: news

JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who are considered at extreme or high risk for open surgery. “Both myself and my CUMC colleagues, Dr. Susheel Kodali and Dr. Torsten Vahl, are extremely pleased to be the first U.S. physicians to treat patients wit...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves JenaValve Source Type: news

JenaValve Getting Closer to its U.S. TAVR Goal
JenaValve Technology is continuing to make progress in bringing its transcatheter aortic valve replacement (TAVR) system to the U.S. market. The Irvine, CA-based company has initiated patient enrollment in an early feasibility study (EFS) of its next generation JenaValve Pericardial TAVR system. The EFS is a prospective, single-arm study of the JenaValve Pericardial TAVR System being conducted at several centers U.S. under an FDA-approved IDE. It is part of a larger, ongoing CE mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers in Europe and New Zealand. â...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Microsoft ’s is developing a glasses-based blood pressure monitor
Microsoft (NSDQ:MSFT)  is developing new blood pressure monitoring tech, called Glabella, which comes equipped on a pair of glasses that passively collects physiological data on the wearer, according to a research paper recently released by the company. A prototype version of the glasses includes optical sensors, processing and storage and communications devices integrated into the frame to continuously collect data, according to the research paper. Sensors on the device collect reflected light intensities to measure blood flow, inertial measurements of the user’s head and temporal differences in pulse even...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Replacement Heart Valves Microsoft Corp. Source Type: news

Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced July 20, originally called for an up-front cash payment of $220 million plus the $50 million reimbursement milestone. That milestone was reached when the Centers for Medicare & Medicaid Services granted&n...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Valve-in-Valve TAVR Matches'Benchmark' of Native TAVR Valve-in-Valve TAVR Matches'Benchmark' of Native TAVR
Outcomes were similar or better compared with those of native-valve transcatheter aortic valve replacement, though longer follow-up will tell if it becomes the default strategy for most failed aortic valves.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 2, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

LivaNova beats Q2 expectations
LivaNova (NSDQ:LIVN) handily topped the consensus forecast for its second-quarter results despite a huge bottom-line slide. Formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, in April the company closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) and paid $250 million to acquire TandemLife and its cardiopulmonary temporary support solutions. LivaNova also acquired ImThera and its implantable sleep apnea treatment for $225 million early this year. LivaNova posted profits of $15.1 mill...
Source: Mass Device - August 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

CMS panel votes on volume requirements for TAVR centers
The Center for Medicare and Medicaid Services’ Medicare Evidence Development and Coverage Advisory Committee this week opened itself to comments and voted on volume requirements for new and existing transcatheter aortic valve replacement programs and operators. Panelists heard data from individuals across the healthcare spectrum, and ended up voting in the middle on most of the issues, according to a Medscape report. Voting was done on a one-to-five scale of confidence, with five showing high confidence in the resolution, according to the report. On considering hospitals with no TAVR experience opening new programs, ...
Source: Mass Device - July 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Source Type: news

Abbott Makes Strong Statement in TMVR Space with SUMMIT
Abbott Laboratories has hit a substantial milestone in its plan to bring the Tendyne transcatheter mitral valve replacement (TMVR) system to the U.S. market. The Abbott Park, IL-based company said it has initiated SUMMIT, a pivotal clinical study of the TMVR system. Up to 1,010 patients will be enrolled in up to 80 sites in the pivotal trial. Abbott said the investigational Tendyne device is the first and only mitral valve replacement that can be repositioned and fully retrieved, allowing the surgeon to precisely place the device during implantation, which could improve patient outcomes. Tendyne is a tri-leaflet, bioprost...
Source: MDDI - July 26, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Abbott launches pivotal US-based Tendyne TMVR trial
Abbott (NYSE:ABT) said today it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation. In the trial, the Abbott Park, Ill.-based company will explore the safety and efficacy of the system in treating patients with mitral regurgitation. Abbot touted the Tendyne as the first and only mitral valve replacement designed to be retrievable and repositionable. “Transcatheter mitral valve replacement represents a new frontier in treating people whose valve does not close properly and who would benefit from a replacement valve in...
Source: Mass Device - July 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Tendyne Holdings Source Type: news

Abbott Begins U.S. Pivotal Trial for the Tendyne Mitral Valve Replacement System to Treat Patients with Heart Valve Disease
- Investigational Tendyne device is first and only repositionable and fully retrievable mitral valve replacement (Source: Abbott.com)
Source: Abbott.com - July 26, 2018 Category: Pharmaceuticals Source Type: news

Endurance athlete hopes new heart valve technology will keep him active
An avid triathlete and marathon runner, Gil Solomon was concerned when an echocardiogram test done in 2014 showed that he had a congenital defect in his heart called bicuspid aortic valve disease. His aortic valve only had two cusps, or leaflets, that opened and closed to regulate blood flow instead of the normal three. The defect causes the valve to narrow, which strains the heart and reduces or blocks blood flow from the heart to the body. The same defect may also weaken the walls of the aorta, the main artery from the heart, which can lead to a tear.Many people, like Solomon, are unaware they have the condition until it...
Source: UCLA Newsroom: Health Sciences - July 25, 2018 Category: Universities & Medical Training Source Type: news

Meril Aims for Emerging Markets with its TAVR Device
Yet another company is throwing its hat into the transcatheter aortic valve replacement system (TAVR) market. However, Meril Lifesciences is going a different route than other established firms in the space and is initially targeting emerging markets. Meril has been around for 10 years and has been developing its MyVal TAVR technology for about six of those. The company’s success in TAVR lies around the fact that larger organizations don’t consider emerging markets as the first option. The company said it would seek out approval in India first and eventually make its way to developed markets. “We are posi...
Source: MDDI - July 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news