Mick Jagger is giving TAVR a boost: Here’s how

Mick Jagger TAVR

Mick Jagger during a concert in Warsaw, Poland in 2018 [Image by Jerzy Bednarski – Own work, CC BY-SA 4.0]

A successful transcatheter aortic valve replacement (TAVR) recovery for rock icon Mick Jagger could be good news for companies such as Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) that make devices for the procedure, according to analysts following the medical device industry.

The Rolling Stone frontman tweeted Friday that he was feeling better and on the mend after undergoing the procedure at a New York hospital.

“We think Mick Jagger’s TAVR procedure will likely raise awareness of aortic stenosis and potentially lead to more TAVR procedures which should benefit the TAVR manufacturers,” Wells Fargo analysts Larry Biegelsen, Lei Huang, Adam C. Maeder, Shagun Singh said in an equity research note dated yesterday.

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Edwards Lifesciences doubles down on Irish plant

Edwards LifesciencesEdwards Lifesciences (NYSE:EW)  reportedly plans to double its investment in a plant it’s building in Ireland that’s expected to add 600 jobs to the local economy.

Last year the Irvine, Calif.-based company said it planned to build a new, 170,000-square-foot facility in Limerick to manufacture delivery components for its transcatheter heart valves. At the time the project was slated to cost about $93.3 million (EU €80 million) and open in 2021.

Today Edwards said it will add another $93.3 million to the tab as it plans to build a larger plant but held to the 2021 timetable as it broke ground on the construction.

“Since we established operations in Ireland last year, we have appreciation for the excellent business environment to help develop our operations. We are also proud that we have had the opportunity to begin to engage in local community activities and initiate educational and professional opportunities for our employees,” chairman & CEO Michael Mussallem said, according to the Irish Times.

Edwards employs 50 workers in Shannon, the newspaper reported.

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Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve

Edwards Lifesciences, CardiAQ Valve, NeovascNeovasc (NSDQ:NVCN) today claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there.

In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today.

Munich’s Higher Regional Court dismissed the remaining claims, finding that CardiAQ “had not contributed to the invention of the Tiara” and ruling “Neovasc to be the rightful inventor and owner of all rights to the disputed Tiara European patent application,” according to Neovasc.

“We are pleased that after full consideration of the evidence, the German courts have now recognized that CardiAQ made no contribution to the invention or development of the Tiara,” CEO Fred Colen said in prepared remarks. “With this decision, which we strongly believe would be confirmed, even if appealed to and accepted as a case by the German Supreme Court, Neovasc is free to pursue its European patent application and has the sole right to commercialize the Tiara in Europe and help treat patients suffering from debilitating mitral valve disease. We will continue to vigorously defend our intellectual property against any attempts by third parties to infringe on these rights.”

The German case is only one front in the companies’ TMVR war. In the U.S., a jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing Tiara. A federal judge in Massachusetts added $21 million in enhanced damages to the decision that November; in January 2017 the Boston court added another $21 million to the judgment.

Edwards, which inherited the beef when it acquired CardiAQ Valve for $400 million in August 2014, did not immediately reply to a request for comment.

Earlier this month Neovasc inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the litigation damages.

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ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications

ACC 2019, Medtronic, Edwards

Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology in the U.S.

Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.

Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at intermediate and high risk for death and complications associated with surgery.

The results, both from trials exploring use of TAVR devices in low-risk patients, earned a standing ovation for presenters at the conference, according to a Medscape report.

In the Medtronic-sponsored Evolut Low Risk study, researchers reported that the use of its self-expanding TAVR system, when compared to open-heart surgery for valve replacements, had a similar rate of disabling stroke or death from any cause at two years at 5.3% versus 6.7%, respectively.

“We now have a minimally invasive procedure that is as good as or better than surgery, while at the same time allowing most patients to be out of the hospital within a few days and be back to their normal activities within a week, and that’s pretty important,” study senior author Dr. Michael Reardon of Houston Methodist Hospital said in a press release.

In the trial, study investigators recruited 1,468 patients with severe, symptomatic aortic stenosis who were deemed to be at low risk of surgery. Patients either received TAVR treatments with one of three Medtronic self-expanding devices, the CoreValve, Evolut R and Evolut Pro, or underwent surgical aortic valve replacement with biopsothetic surgical valves.

The majority of patients in the trial, 74.1%, received Fridley, Minn.-based Medtronic’s Evolut R, while the third-generation Evolut Pro was used in 22.3% and the CoreValve was used in 3.6% of patients, researchers report.

Study researchers said that groups were well-matched in terms of baseline characteristics, with a 2-to-1 ratio of men to women.

At 30 days, TAVR was shown to be statistically superior to SAVR, with a 0.8% rate of disabling stroke or all-cause mortality versus 2.6%, respectively. Rates of death at one month were not statistically different between TAVR and SAVR at 1.3% and 0.5%, respectively, according to the study.

TAVR maintained its superiority to open heart surgery for major stroke at one year, at 0.8% for TAVR patients versus 2.4% in SAVR patients. All-cause mortality rates were similar at 2.4% for TAVR versus 3% for SAVR, while hospitalization and heart failure rates were are 3.2% for TAVR versus a higher 6.5% for SAVR patients.

Quality of life assessments using the Kansas City Cardiomyopathy Questionnaire were higher for TAVR patients than SAVR at 20 versus 9.1 at one month post-procedure, with scores evening out at one year to 22.2 for TAVR and 20.9 for SAVR patients, according to the study.

“TAVR beat surgery at 30 days for mortality or disabling stroke, quality of life and time in the hospital. In other words, you’re more likely to be alive without a disabling stroke, get out of the hospital sooner— in half the time—and have a better quality of life one month after getting a new valve. The mean age of patients in this study was 74, so while this is still not a young group of patients, many of them are very active and whether it be in their professional or social lives, getting back to full range of daily activities is very important to them. At one year, patients with TAVR were more likely than surgery patients to be alive, without a disabling stroke and without a hospital admission for heart failure,” Reardon said in a prepared statement.

Data from echocardiograms indicated that TAVR valves may work better than SAVR valves, with an orifice measurement of 2.2 cm2 vs 2.0 cm2, respectively, and lower mean gradients than surgery at all time points in the trial, according to study data.

Similar to earlier studies, TAVR patients had had more pacemakers and moderate to severe paravalvular leakage, more vascular injuries including dissection, cardiac perforation and access site injuries. SAVR patients reported more cases of atrial fibrillation, transfusions and acute kidney injury, according to the report.

Researchers in the trial plan to follow patients out to 10 years, exploring long-term data as well as cost-effectiveness. Study investigators said that the study was limited by short follow-up time, and that the trial excluded patients with bicuspid aortic valves and those with anatomic incompatibilities.

“We’ve now looked at a broad risk spectrum of patients—those at high, intermediate and low surgical risk—and these series of trials have shown that TAVR is better than or as good as surgery in terms of disabling strokes and deaths from all causes. When we look at secondary outcomes of quality of life and functional recovery, these seem to favor TAVR at this point. Given this data, it now seems reasonable to consider moving TAVR in low risk patients to a class I guideline indication on par with surgery for patients with severe aortic stenosis,” Reardon said in prepared remarks.

In a separate presentation on the same day, Edwards Lifesciences touted that data from its PARTNER 3 study of its Sapien 3 TAVR system indicated a reduction in death, stroke and rehospitalization of 46% at one year.

A total of 1,000 patients with severe aortic stenosis deemed at low risk for surgery were recruited for the PARTNER 3 trial, the Irvine, Calif.-based company said. The group was younger, at 73 years average, with fewer co-morbid conditions and fewer symptoms than previous PARTNER trials, with a similar two-to-one ratio of men to women.

The primary endpoint of the trial was a combined rate of all-cause death, any stroke and re-hospitalizations at one-year post procedure, Edwards said.

Results from the trial indicated a 1% mortality rate for TAVR patients versus 2.5% in SAVR patients, with a 1.2% stroke risk for TAVR patients versus a higher 3.1% rate for SAVR patients. SAVR patients were also more likely to be rehospitalized, at an 11% rate, versus only 7.3% for TAVR patients.

“This is a landmark study because it involves 80 percent of the people who are currently being treated with surgery for aortic stenosis. Our hope was that TAVR would be non-inferior or comparable to surgery, and we were surprised to find an almost 50 percent reduction in the primary endpoint, from 15.1% in the surgical group to 8.5% with TAVR. This is beyond anything we could have expected, mostly because surgery is so good in treating aortic stenosis in these low risk patients. Taken by themselves, each component of the primary endpoint also favored TAVR, which is confirmatory evidence of the outcome,” lead study author Dr. Martin Leon of the New York-Presbyterian/Columbia University Irving Medical Center said in a press release.

Evaluation of secondary endpoints indicated that hospital stay length was reduced from seven to three days for TAVR patients, and that TAVR patients had more rapid 30-day functional recovery based on six-minute walk tests and quality of life measurements.

Post-operative or new onset atrial fibrillation was reported in approximately 40% of SAVR patients, compared to only 5% in TAVR patients. Major vascular complications were also similar between groups, Edwards said.

Patients in the TAVR arm were more likely to need new permanent pacemakers, at 6.5% for TAVR patients versus 4% for SAVR patients, while rates of moderate to severe paravalvular leaks were similar between groups.

“Surgery eventually catches up to TAVR in terms of functional recovery and quality of life, but it takes several months. TAVR is a less invasive procedure, so we expect an earlier return to normal daily activities compared with surgery. There has also been an evolution of TAVR technology, increased operator experience and enhanced procedural techniques, all of which combine to lower complications after TAVR especially in the lowest risk patients,” Leon said in a prepared statement.

Researchers in the trial said it was limited by its breadth and said that longer-term follow-ups would be needed to explore the viability of TAVR devices. Study investigators added that they plan to follow patients in the trial out to ten years.

“The results of this trial in low risk patients indicates that the choice of TAVR versus surgery for severe aortic stenosis should be independent of surgical risk profile assessments. The combined rate of death and disabling stroke at one year was only 1 percent with TAVR, which was an unexpectedly favorable outcome. Based on these findings, the choice of TAVR versus surgery should be a shared decision-making process that respects patient preferences and considers some of the knowledge gaps, especially in treating young patients,” Leon said in prepared remarks.

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Edwards Lifesciences gets in on Corvia, Mitralign

Edwards LifesciencesEdwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets.

Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said.

The Irvine, Calif.-based company also said it bought “certain” Mitralign assets, including intellectual property and associated clinical and regulatory experience. Mitralign, also based in Tewksbury, is developing an annuloplasty system for treating functional mitral and tricuspid regurgitation.

Edwards said the transactions are not expected to affect its financial outlook for 2019.

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Edwards Lifesciences wins CE Mark for Pascal mitral repair device

Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) said late yesterday that it won CE Mark approval in the European Union for its Pascal transcatheter valve repair system intended to treat mitral regurgitation.

The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area, the Irvine, Calif.-based company said.

The newly launched system also includes a delivery system intended for independent leaflet capture to optimize leaflet position, Edwards said.

“Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality. The introduction of the Pascal system to clinicians and patients in Europe provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation,” transcatheter mitral and tricuspid therapies corp VP Bernard Zovighian said in a press release.

Edwards said that is engaged in a U.S. pivotal trial of the device, the CLASP IID study, which it hopes will support eventual FDA clearance of the system.

“The Pascal system is uniquely designed for optimized valve leaflet capture and coaptation, and to help operators achieve their ultimate goal of safe and effective mitral regurgitation reduction for their patients,” CLASP sutdy investigator Konstantinos Spargias of Greece’s Hygeia Hospital said in a prepared statement.

Last week, Edwards said that it inked a deal to acquire CAS Medical System (NSDQ:CASM) and its non-invasive brain tissue oxygenation monitoring tech for approximately $100 million.

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FDA labels Edwards Lifesciences’ recall of Swan Ganz thermodilution caths as Class I

Edwards Lifesciences

The FDA has labeled a select recall of Edwards Lifesciences‘ (NYSE:EW) Swan-Ganz Thermodilution catheters over issues with the lumen assembly as Class I.

Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The Irvine, Calif.-based company’s Swan-Ganz Thermodilution catheters function as a diagnostic tool to determine hemodynamic pressures and cardiac output and are intended for use with a compatible cardiac output computer.

The catheters have indications for measuring hemodynamic conditions through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions, according to an FDA release. The distal port also allows for sampling of mixed venous blood for assessing oxygen transport balance and calculating derived parameters including oxygen consumption, oxygen utilization coefficient and intrapulmonary shunt fraction, according to the release.

A total of 875 devices are being recalled due to a non-conformance issue involving catheters with incorrect lumen assemblies which can cause reversal of the lumens. If lumens are reversed, a clinician may note PA and CVP pressure values and waveforms in reverse, according to the FDA release.

Edwards has reportedly been in contact with customers about the issue since December 21, 2018, according to the release.

Last week, Edwards Lifesciences posted fourth quarter and full year 2018 earnings that topped earnings per share consensus on Wall Street, but missed on full-year sales expectations.

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Edwards Lifesciences posts posts Street-beating Q4, mixed-bag 2018 earnings

Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) today posted fourth quarter and full year 2018 earnings that topped earnings per share expectations on Wall Street, but missed on full-year sales consensus.

The Irvine, Calif.-based company posted profits of $7 million, or 3¢ per share, on sales of $977.7 million for the three months ended December 31, seeing a swing to black ink on the bottom line while sales grew 10% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share for the quarter were $1.17, just in line with the consensus on Wall Street where analysts expected to see sales of approximately $976 million, which the company topped.

For the full year, Edwards Lifesciences posted profits of $722.2 million, or $3.38 per share, on sales of $3.7 billion, for bottom-line growth of 23.7% while sales grew 8.4% compared with the previous year.

After adjusting to exclude one-time items, earnings per share for the year were $4.70, in line with the consensus on Wall Street where analysts expected to see sales of $3.8 billion, which the company narrowly missed.

“We are pleased to report strong fourth quarter performance that delivered 10 percent sales growth on an underlying basis, consistent with our expectations, driven by our portfolio of innovative technologies.  For the full year 2018, we reported 10 percent growth on an underlying basis, also in line with our guidance.  Profitability was also strong in 2018, with adjusted EPS growing over 20 percent, even as we continued to invest aggressively in our innovation initiatives and infrastructure. We are as convinced as ever in the tremendous opportunity to improve patients’ lives by addressing deadly conditions and bringing significant value to the healthcare system,” chair & CEO Michael Mussallem said in a prepared statement.

The company reiterated financial guidance for the 2019 fiscal year, expecting to post adjusted earnings per share of between $5.05 and $5.30.

For its upcoming first quarter of 2019, Edwards Lifesciences said that it expects to post sales of between $950 million and $1.01 billion and adjusted EPS of between $1.15 and $1.25.

“Our strong 2018 performance reinforces our confidence in our focused innovation strategy and our longer term outlook, and we anticipate an exciting 2019 as we pursue important therapies that will benefit many more patients. We look forward to launching a number of new technologies as well as achieving important milestones across all of our product lines. We are confident that our differentiated strategy and focus on leadership will continue to create value and benefit the patients we serve,” Mussallem said in a prepared release.

Shares in Edwards Lifesciences rose 1% today, closing at $170.42.

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Edwards Lifesciences posts Street-beating Q4, mixed-bag 2018 earnings

Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) today posted fourth quarter and full year 2018 earnings that topped earnings per share consensus on Wall Street, but missed on full-year sales expectations.

The Irvine, Calif.-based company posted profits of $7 million, or 3¢ per share, on sales of $977.7 million for the three months ended December 31, seeing a swing to black ink on the bottom line while sales grew 10% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share for the quarter were $1.17, just in line with the consensus on Wall Street where analysts expected to see sales of approximately $976 million, which the company topped.

For the full year, Edwards Lifesciences posted profits of $722.2 million, or $3.38 per share, on sales of $3.7 billion, for bottom-line growth of 23.7% while sales grew 8.4% compared with the previous year.

After adjusting to exclude one-time items, earnings per share for the year were $4.70, in line with the consensus on Wall Street where analysts expected to see sales of $3.8 billion, which the company narrowly missed.

“We are pleased to report strong fourth quarter performance that delivered 10 percent sales growth on an underlying basis, consistent with our expectations, driven by our portfolio of innovative technologies.  For the full year 2018, we reported 10 percent growth on an underlying basis, also in line with our guidance.  Profitability was also strong in 2018, with adjusted EPS growing over 20 percent, even as we continued to invest aggressively in our innovation initiatives and infrastructure. We are as convinced as ever in the tremendous opportunity to improve patients’ lives by addressing deadly conditions and bringing significant value to the healthcare system,” chair & CEO Michael Mussallem said in a prepared statement.

The company reiterated financial guidance for the 2019 fiscal year, expecting to post adjusted earnings per share of between $5.05 and $5.30.

For its upcoming first quarter of 2019, Edwards Lifesciences said that it expects to post sales of between $950 million and $1.01 billion and adjusted EPS of between $1.15 and $1.25.

“Our strong 2018 performance reinforces our confidence in our focused innovation strategy and our longer term outlook, and we anticipate an exciting 2019 as we pursue important therapies that will benefit many more patients. We look forward to launching a number of new technologies as well as achieving important milestones across all of our product lines. We are confident that our differentiated strategy and focus on leadership will continue to create value and benefit the patients we serve,” Mussallem said in a prepared release.

Shares in Edwards Lifesciences rose 1% today, closing at $170.42.

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Chinese national draws 27-month sentence in Medtronic, Edwards trade theft case

gavel, legal

A Chinese National engineer who stole confidential trade secrets from Edwards Lifesciences (NYSE:EW) and ev3, formerly owned by Covidien and now a subsidiary of Medtronic (NYSE:MDT), has been sentenced to 27 months in federal prison, according to a posting from the U.S. Attorney’s Office for the Central District of California.

Wenfeng Lu, 46, pleaded guilty last May to six counts of unauthorized possession and attempted possession of trade secrets. Lu admitted that he stole secrets from the Irvine, Calif.-based labs of both Edwards and ev3 while he worked there from January 2009 until his arrest in 2012, according to the report.

Lu was initially employed by ev3 and later moved to Edwards. At both companies, Lu copied multiple documents with technical information and trade secrets and put them on his personal laptop at home.

During his time under both ev3 and Edwards employment, Lu traveled to the People’s Republic of China multiple times, at times directly after he stole secrets from the medtech firms, according to the report.

In addition to the thefts, Lu was preparing to launch a company to manufacture devices using technology stolen from his employers, according to the report.

“In furtherance of his business, defendant [Lu] applied to the PRC government for funding designed to attract technological talent from places such as the United States, and was selected to receive approximately $2 million RMB (about $328,000 USD) and free rent for a period of three years in a laboratory in a technology park located in Nanjing Province in the PRC. The money and laboratory space was part of a program sponsored by the PRC government to encourage scientists of Chinese descent to return to the PRC with intellectual property to develop biomedical technology in the PRC,” prosecutors wrote in a sentencing memorandum filed with the court, according to the AG report.

Lu was arrested in November 2012 as he was preparing to board a plane to the PRC.

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