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Variations in Aortic Root Anatomy Could Influence TAVR Outcomes Variations in Aortic Root Anatomy Could Influence TAVR Outcomes
Individual variations in the membranous septum and in the rotation of the aortic root could have implications for transcatheter aortic valve replacement (TAVR).Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 13, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Boston Scientific wins FDA nod for Vercise DBS for treating Parkinson ’ s disease
Boston Scientific (NYSE:BSX) said yesterday it won FDA approval for its Vercise deep brain stimulation system designed to treat symptoms of Parkinson’s disease. The device, initially launched in Europe in 2012, was developed based on cochlear implant technology and is designed to stimulate a targeted region of the brain through implanted leads powered by an implantable pulse generator.  The device also has the ability to independently control the amount of current delivered on each lead, the company said. “This approval marks an important step for patients who will now have the choice to be treat...
Source: Mass Device - December 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Boston Scientific Source Type: news

Edwards Lifesciences raises 2017 outlook, details 2018 goals
Edwards Lifesciences (NYSE:EW) today raised its outlook for the rest of this year and set its goals for the coming year, saying it expects to post earnings growth of about 12% on a roughly 9% sales gain in 2018 and pledging “aggressive” investment in R&D. The Irvine, Calif.-based heart valve maker, which yesterday acquired mitral valve repair developer Harpoon Medical for $100 million in cash plus another $150 million in potential milestones, released the numbers at its annual investor conference in New York City. For 2017, Edwards upped the forecast for adjusted earnings per share to $3.65 t...
Source: Mass Device - December 7, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Wall Street Beat Edwards Lifesciences Source Type: news

Edwards Lifesciences acquires mitral repair dev Harpoon Medical for $100 million
Edwards Lifesciences (NYSE:EW) said today it acquired mitral valve repair developer Harpoon Medical for $100 million in cash, with the potential for an additional $150 million in milestone payments over 10 years. Harpoon is developing a system designed to enable echo-guided repair of mitral valve regurgitation through the stabilization of prolapse leaflets to restore coaptation and valve function. The device is currently investigational, though Harpoon is hopeful it will receive CE Mark approval in the European Union in the near future. “We believe the addition of Harpoon Medical’s technology and talented ...
Source: Mass Device - December 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions Replacement Heart Valves Edwards Lifesciences Harpoon Medical Source Type: news

Edwards Buys Harpoon for up to $250 Million
Edwards Lifesciences may be best known for its leadership in transcatheter valve therapies, but the company appears to be turning to its surgical valve portfolio as part of its growth strategy for the coming year. The company's acquisition of Harpoon Medical, announced Wednesday afternoon, is the first major indicator of this shift. Harpoon is developing beating-heart repair technology for degenerative mitral regurgitation (DMR). Edwards paid $100 million up front for Harpoon and agreed to pay up to $150 million more in milestone payments over the next 10 years. The company has had an eye on Harpoon since 2015 wh...
Source: MDDI - December 6, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Finally – FDA Offers Guidance on 3-D Printed Products
Not so long ago, the concept of 3-D printed medical devices seemed like something out of a science fiction movie. But the technology is very much a reality, and FDA Commissioner Scott Gottlieb, MD, said the agency is preparing for a significant wave of new technologies that are "nearly certain to transform medical practice." As part of that preparation, the agency released a comprehensive technical framework this week to advise manufacturers creating medical products on 3-D printers. FDA is the first regulatory agency in the world to do so. The agency said it reviewed more than 100 3-D printed devices currently o...
Source: MDDI - December 6, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: 3-D Printing Regulatory and Compliance Source Type: news

Can Boston Scientific Bounce Back from Lotus Setback?
Boston Scientific shares took a beating Tuesday after the company abruptly backed out of a scheduled appearance at the annual Piper Jaffray healthcare conference in New York. As investors seemed to fear, the sudden change of plans foreshadowed another Lotus setback. The company's stock (NYSE: BSX) dropped 7.5% by market close on Tuesday, slashing Boston Scientific's market cap by about $2.9 billion. About three hours after the close, the company said it had pushed back its previously-reported timelines for re-introducing the Lotus Edge aortic valve system in Europe, and the filing of a final pre-market approval (PMA) modul...
Source: MDDI - November 29, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Cardiovascular Source Type: news

Boston Scientific takes a $3B hit on latest Lotus valve delay
Boston Scientific (NYSE:BSX) saw its market capitalization lose $3 billion after yesterday revealing another delay for its Lotus replacement heart valve. The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February over issues with its locking mechanism, said it no longer expects the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018. “We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients w...
Source: Mass Device - November 29, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Wall Street Beat Boston Scientific Source Type: news

Tiny incision could save thousands from heart surgery
Pioneering  British surgeons are performing heart-valve surgery via a minute incision in the nipple – sparing patients from a large cut and breaking the breastbone to reach the organ. (Source: the Mail online | Health)
Source: the Mail online | Health - November 25, 2017 Category: Consumer Health News Source Type: news

Aortic Valve Replacement Improves Survival in High-risk Patients Aortic Valve Replacement Improves Survival in High-risk Patients
Aortic valve replacement (AVR) improves survival in patients with severe aortic regurgitation and severely reduced left-ventricular ejection fraction (LVEF), according to a database review.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - November 17, 2017 Category: Radiology Tags: Internal Medicine News Source Type: news

Danny ’s journey to a biventricular heart
The first hint that something wasn’t quite right with Danny Sanchez-Garcia’s heart came at his mom’s six-month prenatal visit. “There was a little blip on the ultrasound, but then it was gone on the next one, so they didn’t think it was anything and I didn’t worry any more about it,” says Danny’s mom, Cynthia. Cynthia was overjoyed when Danny was born at her local hospital seeming perfectly healthy. But as the hospital staff monitored Danny overnight, they noticed his oxygen level was lower than normal and decided to run more tests. His doctors believed the tests pointed to a...
Source: Thrive, Children's Hospital Boston - November 15, 2017 Category: Pediatrics Authors: Ellen Greenlaw Tags: Diseases & Conditions Our Patients’ Stories Biventricular Repair Complex Biventricular Repair Program congenital heart valve program double outlet right ventricle Dr. Christopher Baird Dr. Roger Breitbart ECMO Pulmonary atresia tetra Source Type: news

Xeltis raises $53m Series C round for replacement heart valve programs
Xeltis said today that it closed a Series C round worth more than $53 million (€45 million) for the bioresorbable heart valve technology it’s developing. The Eindhoven, Holland- and Zurich-based company said the round was led by “a global strategic investor,” joined by Ysios Capital, “a number of large private investors,” prior backers LSP, Kurma Partners and VI Partners and other previously involved private investors. Xeltis said it plans to use the cash to back the clinical programs for its aortic and pulmonary valves, built on endogenous tissue restoration technology. That&rs...
Source: Mass Device - November 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Regenerative Medicine Replacement Heart Valves Wall Street Beat Xeltis Source Type: news

Neovasc looks to raise $65m to cover trade secret ruling, trials
Neovasc (NSDQ:NVCN) said last week that it’s looking to raise more than $65 million in a stock offering and a private placement as it seeks to come up with a $42 million shortfall stemming from its trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal jud...
Source: Mass Device - November 13, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Neovasc Inc. Source Type: news

Aortic Valve Stenosis (Symptoms, Causes, Surgery)
Title: Aortic Valve Stenosis (Symptoms, Causes, Surgery)Category: Diseases and ConditionsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 11/13/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - November 13, 2017 Category: Cardiology Source Type: news

Medtronic shares up on Q2 prelims, limited Hurricane impact
Medtronic (NYSE:MDT) yesterday released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share. The Fridley, Minn.-based company said it expects to post sales of $7.05 billion, which is down 4% from the same quarter the prior year but still ahead of the $6.87 billion consensus on Wall Street. Medtronic said the decline was mainly driven by its divestiture of multiple business to Cardinal Health earlier this year. Medtronic said it was able to limit the impact of Hurricane Maria against its origi...
Source: Mass Device - November 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Medtronic Source Type: news

Heart valve replacement success may depend on age, valve type
(Reuters Health) - People who need a heart valve replaced often face a dilemma: should they have a mechanical valve made of graphite or a biological valve derived from a cow or pig? A new study suggests the answer depends on the age of the patient and which of the heart ’s valves needs to be replaced. (Source: Reuters: Health)
Source: Reuters: Health - November 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Abbott Scores Japan Approval for MitraClip
Patients in Japan who previously had limited options for mitral regurgitation (MR) can potentially benefit from Abbott's MitraClip device. Japan's Ministry of Health, Labour, and Welfare (MHLW) has approved the catheter-based therapy for MR, a progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart. During Abbott's third-quarter earnings call, as transcribed by Seeking Alpha, CEO Miles White told investors that a continued global uptick of MitraClip sales led double-digit growth in the structural heart category. Now that the device has been approved in Jap...
Source: MDDI - November 6, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Japan clears Abbott ’ s Mitraclip
Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation. Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added. The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Abbott Source Type: news

Abbott's MitraClip Approved as First Transcatheter Mitral Valve Repair Device in Japan
First minimally invasive device to treat people in Japan with common leaky heart valve for whom surgery is too risky More than 50,000 patients worldwide have been treated with the MitraClip therapy ABBOTT PARK, Ill., Nov. 6, 2017 -- (Healthcare Sales... Devices, Interventional, Cardiology, Regulatory Abbott, MitraClip, Mitral Valve Repair, mitral regurgitation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 6, 2017 Category: Pharmaceuticals Source Type: news

Medtronic wins CE Mark for Intellis SCS, PNS systems
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Intellis spinal cord stimulation and peripheral nerve stimulation systems designed to treat chronic pain. The Fridley, Minn.-based company touted the Intellis as the world’s smallest fully implantable SCS neurostim. The newly-cleared system includes improved battery performance and is managed through the use of a Samsung Galaxy Tab S2 tablet. “Medtronic’s goal is to simplify treatment and improve the patient experience with personalized therapy that provides long-term pain relief and helps restore function. The...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Pain Management Regulatory/Compliance Medtronic Source Type: news

Neovasc surges on news of appeal, FDA nod for clinical trial
Neovasc (NSDQ:NVCN) shares surged today in pre-market trading after the replacement heart valve maker said it’s exhausted the appeals process in its trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve and that it won an FDA nod for a clinical trial. A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal judge in ...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Legal News Replacement Heart Valves CardiAQ Valve Technologies Edwards Lifesciences Neovasc Inc. Source Type: news

Abbott's MitraClip Approved as First Transcatheter Mitral Valve Repair Device in Japan
- First minimally invasive device to treat people in Japan with common leaky heart valve for whom surgery is too risky (Source: Abbott.com)
Source: Abbott.com - November 6, 2017 Category: Pharmaceuticals Source Type: news

TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke. Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes. Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11....
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

LivaNova swings to Q3 black
LivaNova (NSDQ:LIVN) today swung to profitability during the third quarter and raised its earnings outlook for the rest of 2017, after handily beating the consensus forecast on Wall Street. The London-based medical device company reported profits of $27.8 million, or 57¢ per share, on sales of $309.7 million for the three months ended Sept. 30, compared with losses of -$1.6 million during Q3 2016, for sales growth of 4.9%. Adjusted to exclude one-time items, earnings per share were 93¢, 15¢ ahead of consensus on The Street, where analysts were looking for sales of $300.5 million. “We delivered sol...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

Heart Surgery May Be Safer in Afternoon Than in Morning
Having heart valve replacement later in the day was tied to fewer complications. (Source: NYT Health)
Source: NYT Health - November 1, 2017 Category: Consumer Health News Authors: NICHOLAS BAKALAR Tags: Heart Surgery and Surgeons Source Type: news

TCT 2017: Medtronic touts early Intrepid TMVR results
The post TCT 2017: Medtronic touts early Intrepid TMVR results appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Intermediate-Risk TAVR More Bang for the Buck Than Surgery Intermediate-Risk TAVR More Bang for the Buck Than Surgery
Despite higher procedural costs, transcatheter aortic-valve replacement provides greater quality-adjusted life expectancy and lower costs in the long term than the surgical option.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 1, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

TCT 2017: Edwards touts cost savings in Sapien 3
The post TCT 2017: Edwards touts cost savings in Sapien 3 appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver. Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT. One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group ana...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Tiny 'anchor' to fix leaky heart valves - without surgery
Thousands of Britons have leaky heart valves. Olasumbo Yates, 56, (pictured) from London, took part in a trial for a new implant that avoids the need for open surgery. (Source: the Mail online | Health)
Source: the Mail online | Health - October 31, 2017 Category: Consumer Health News Source Type: news

HighLife Medical raises $14m for transcatheter mitral valve replacement
HighLife Medical said today that it raised more than $14 million for the replacement heart valve it’s developing to treat mitral regurgitation. Paris- and Irvine, Calif.-based HighLife said the €12.3 million round was led by European venture capital shop Soffinova Partners, joined by prior backers LivaNova (NSDQ:LIVN) and HighLife founder & CEO Georg Börtlein – who also co-founded CoreValve, the aortic valve replacement company acquired in 2009 by Medtronic (NYSE:MDT) for $700 million. HighLife’s transcatheter mitral valve replacement uses a ring around the diseased valve&rsqu...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat HighLife Source Type: news

Timing of Aortic-Valve Surgery
Linked to Better Outcomes (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - October 30, 2017 Category: General Medicine Source Type: news

Bicuspid Aortic Valve Morphology Differs Between Asians and Europeans Bicuspid Aortic Valve Morphology Differs Between Asians and Europeans
Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - October 27, 2017 Category: Surgery Tags: Pediatrics News Source Type: news

Afternoon open heart surgery 'leads to fewer complications'
Conclusion This study found evidence of an effect that's worth investigating further to see if there are real differences in heart muscle function and risk of complications from heart surgery at different times of the day. However, there were some limitations: It took place at a single hospital, with a relatively small number of people undergoing operations. The laboratory study found differences in gene activity that suggested the body clock may play a role in making the heart better able to tolerate loss of oxygen and subsequent re-oxygenation. However, there may be other explanations for these differences. For example, ...
Source: NHS News Feed - October 27, 2017 Category: Consumer Health News Tags: Heart/lungs Source Type: news

Timing of Aortic-Valve Surgery Linked to Better Outcomes Timing of Aortic-Valve Surgery Linked to Better Outcomes
New research suggests circadian rhythms may orchestrate perioperative myocardial injury and that targeting so-called clock genes may offer a potential strategy for cardioprotection.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 27, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Aortic Valve Replacement: Afternoon Surgery Linked to Fewer Adverse Events (FREE)
By Kelly Young Edited by Andr é Sofair, MD, MPH, and William E. Chavey, MD, MS Having cardiac surgery in the afternoon rather than the morning is linked to better outcomes, suggests a Lancet study.First, researchers studied consecutive patients who underwent on-pump cardiac surgery for aortic valve replacement: 300 patients who … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - October 27, 2017 Category: Primary Care Source Type: news

Afternoon heart surgery has lower risk of complications, study suggests
Heart attacks and heart failure less common in patients having heart operations in the afternoon as opposed to the morning, say researchersPatients undergoing open heart surgery in the afternoon have a lower risk of potentially fatal complications than those undergoing operations in the morning, new research suggests.The study found that events including heart attacks and heart failure were less common among those who had undergone a valve replacement operation in the afternoon.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - October 26, 2017 Category: Science Authors: Nicola Davis Tags: Medical research Heart disease Society Heart attack Science Biology Source Type: news

TAVR: Boston Scientific ’ s Acurate Neo, Edwards ’ Sapien 3 show similar results at 30 days
Outcomes from transcatheter aortic valve replacement procedures with both Boston Scientific‘s (NYSE:BSX) Acurate Neo and Edwards Lifesciences‘ (NYSE:EW) Sapien 3 have been found to be similar at 30 days, according to a new study reported by Healio. Results from the trial were published in the journal JACC: Cardiovascular Interventions, according to the report. The study explored the use of both Edwards’ balloon-expandable valve and Boston Scientific’s self-expanding valve in a total of 933 patients undergoing TAVR procedures. The study analyzed 622 patients treated with Edwards Sapien 3 and 311...
Source: Mass Device - October 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news

Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week. In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures. Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints ...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Claret Medical raises $21m
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted this week. The Santa Rosa, Calif.-based company is not seeking to raise any more funds in the round and has not yet stated how it plans to spend the funds it raised. Money in the round came from 35 anonymous investors, according to the SEC filing, with the 1st sale noted on June 22. Earlier this week, Claret Medical 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 mortali...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Medtech Industry Frowns on India Price Caps
In response to India’s price capping for certain medical devices, medtech industry group AdvaMed is calling for the perks India enjoys under the U.S. Generalized System of Preferences (GSP) to be withheld. This year, India’s National Pharmaceutical Pricing Authority (NPPA) implemented price caps on coronary stents and knee implants. The coronary stent pricing control went into effect in February 2017 and was followed in August by pricing control on knee implants. The price caps inflicted steep cuts ranging from 70%–85%. Now, AdvaMed has filed a petition with the U.S. Trade Representative asking for India&...
Source: MDDI - October 18, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

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