Boston Scientific inks $202m deal to buy Cryterion Medical

Boston Scientific (NYSE:BSX) said today that it plans to pay $202 million upfront to acquire Cryterion Medical and its single-shot cryoablation device designed to treat atrial fibrillation.

Adding a cryoballoon platform to its portfolio positions the company as the first to have both cryothermal and radiofrequency balloon-based ablation therapies at its disposal, the medtech giant touted.

Boston Scientific has invested in California-based Cryterion Medical since its beginnings in 2016 and the $202-million pricetag represents the remaining 65% stake.

Single-shot ablation therapies are the fastest growing sub-segment within the $5 billion electrophysiology market, Boston Scientific reported.

Cryterion Medical’s platform leverages cryothermal energy to disrupt the irregular electrical signals that can trigger atrial fibrillation. The company’s device is undergoing clinical investigation in Europe and Cryterion Medical plans to submit for CE Mark clearance in early 2019. The company is also slated to pursue regulatory approval in the U.S., aiming to start enrolling patients in an IDE trial next year.

“Initial clinical study results demonstrate that our system has a promising safety profile as well as acute efficacy,” Keegan Harper, Cryterion Medical’s president & CEO, said in prepared remarks. “We look forward to bringing this advanced cryoablation system to market with the support of Boston Scientific.”

“The acquisition of Cryterion Medical enhances our AF ablation procedure offerings, allowing physicians to select a therapeutic option based on clinical preference and specific patient needs,” Dr. Kenneth Stein, SVP & CMO of Boston Scientific’s rhythm management & global health policy unit, added. “We are committed to providing physicians with a comprehensive suite of therapies that lead the way for clinical advancements and address the needs of the increasing population of patients with AF.”

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FDA approves ReCor Medical’s pivotal ultrasound denervation study

ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension.

The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s safety and ability to lower blood pressure.

ReCor plans to start enrolling patients for Radiance-II in October.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” Leslie Coleman, VP of regulatory & medical affairs, said in prepared remarks. “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our Solo, Trio, Require, and Radiance-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our steering committee and medical advisors have been instrumental in the design of the global Radiance clinical program – including the Radiance-II pivotal study – for the US, EuropeJapan and Korea,” Helen Reeve-Stoffer, VP of clinical affairs, added. “Given the recent positive Solo results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide. Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise system to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

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CHF Solutions closes $5m round

CHF Solutions (NSDQ:CHFS) today closed a $5.4 million offering with a fully-exercised underwriter’s over-allotment option.

The Eden Prairie, Minn.-based company floated 2.2 million shares of its common stock at $2.12 per share and an additional 332,239 shares at the public offering price as part of a 45-day underwriter’s option to purchase additional shares.

Ladenburg Thalmann & Co acted as sole book-running manager for the offering, with Dawson James Securities acting as co-manager, according to a press release.

CHF Solutions said it plans to use net proceeds for general corporate purposes, including the expansion of its field sales force and commercial organization.

In May, CHF Solutions saw shares fall after the heart-focused medical device maker missed expectations on Wall Street with its first quarter earnings results.

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CMS opens NCA to reconsider TAVR coverage

The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures.

Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers.

Requirements in the 2012 decision included specific procedural volume requirements for heart teams and hospitals’ as well as mandatory participation in a registry.

In a letter requesting reconsideration of the decision, Providence Health & Services of Southern California’s Dr. Peter Pelikan, Dr. Richard Wright and Dr. John Robertson said that since 2012, TAVR procedures have become more standard and safer, and urged for reconsideration of coverage.

The doctors said that initial approval of TAVR hospital programs were based on volumes of non-TAVR procedures, and that procedural volume was used “as a surrogate for program quality,” which was understandable given the novel nature of the procedure.

“Today, TAVR has become a commonplace and safe procedure, with indications now expanded from high risk to intermediate risk patients as well. Procedural volumes across the country are increasing, with excellent outcomes. Thus, the early motivation for the NCD, insuring quality for a new and high risk procedure, is no longer relevant,” Providence Health & Services authors wrote in their letter.

Medtech dev Edwards Lifesciences (NYSE:EW), maker of the Centera and Sapien lines of TAVR devices, also showed support for the reconsideration and urged CMS to expand availability to reach more patients.

“As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients’ access to this life-saving care,” Edwards wrote in a press release.

CMS said that on July 25, it will convene a panel of its Medicare Evidence Development & Coverage Advisory Committee seeking its recommendations “regarding the evidence on procedural volume requirements for hospitals and heart team members” necessary to launch and maintain TAVR programs.

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Analyst’s rating changes push Cardiovascular Systems up, NuVasive and Globus down

Ratings changes by an analyst with Bank of America-Merrill Lynch elevated one medical device company’s stock today in pre-marker trading but pushed two others down.

Appearing this morning on Bloomberg television, BAML’s Bob Hopkins said Wall Street isn’t foucsed enough on the July 31 investor day at Cardiovascular Systems (NSDQ:CSII), according to Seeking Alpha. The St. Paul, Minn.-based company plans to emphasize new product releases in the near term and could be in store for sustained double-digit earnings growth, Hopkins said.

The analyst upgraded his rating on CSII shares from “underperform” to “buy” and boosted his price target from $30 to $40, representing a 33% premium on yesterday’s $30.78 closing price. The upgrade sent the stock up 1.1% to $31.12 today before the market’s opening.

NuVasive Inc. (NSDQ:NUVA) and Globus Medical (NYSE:GMED) didn’t fare as well, as Hopkins downgraded both stocks to “underperform.

That sent NUVA shares down -2.2% to $51.60 apiece pre-market and pared -2.7% from GMED shares, which were at $51.85 before the open.

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Medtronic can’t slip whistleblower’s CRM suit

Medtronic (NYSE:MDT) must face a whistleblower’s lawsuit accusing it of running a kickbacks scheme to encourage doctors to implant its cardiac rhythm management devices.

Plaintiff Cathleen Forney worked for Fridley, Minn.-based Medtronic for 16 years until she was fired from her role as a district service manager for the cardiac & vascular division in 2012, according to court documents. Forney alleged in a 2012 lawsuit brought under the False Claims Act that the company provided free services to hospital purchasing decision-makers “to persuade healthcare providers to purchase Medtronic devices.”

The service incentives covered device checks and interrogations, implant services and practice management consulting, according to the documents. Medtronic moved for summary judgment to have the suit tossed on the grounds that Forney’s allegations were already publicly known.

The FCA’s public disclosure bar was altered when the Affordable Care Act was put in place in 2010, restricting the material that counts as public disclosure and broadening exceptions allowed under the bar if the whistleblower is deemed an original source.

Judge Edward Smith of the U.S. District Court for Eastern Pennsylvania ruled this week that although “the vast majority of the relator’s allegations of fraud were contained in valid prior public disclosures,” Forney still qualifies as an original source.

“Thus, despite the presence of prior public disclosures that advanced substantially the same allegations of fraud as the relator does here, the court denies the motion for summary judgment,” Smith wrote June 4 in a 36-page ruling.

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Philips to acquire EPD solutions in $293m upfront deal

Royal Philips (NYSE:PHG) said today it inked a deal to acquire image-guided cardiac arrhythmia treatment dev EPD Solutions for $293 million (EU €250 million) upfront with a possible additional $246.2 million (EU €210 million) upon completion of the deal based on certain milestones.

EPD Solutions produces cardiac imaging and navigation systems designed to aid electrophysiologists in navigating the heart through a detailed 3D image of the cardiac anatomy, Amsterdam-based Philips said. The system is also designed to identify the location and orientation of catheters during the diagnostic and therapeutic procedures for cardiac arrhythmias, the company added.

“EPD’s breakthrough innovation provides detailed 3D anatomical information of the heart during cardiac arrhythmia ablation procedures that is unique in the industry. The technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. This acquisition will strengthen our ability to improve the lives of arrhythmia patients, and is entirely consistent with our strategic plan to broaden our image-guided therapy solutions portfolio and drive long-term profitable growth for Philips,” Philips CEO Frans van Houten said in a press release.

Philips said the acquisition will complement its existing portfolio of interventional imaging systems, smart caths, planning and navigation software. The acquisition is expected to close next month, after which EPD and its employees will become part of Philips image-guided therapy business.

“I am very pleased that Philips will become the home for our innovation, our business and our people. Philips’ expertise and leadership in interventional imaging and navigation is an excellent strategic fit with EPD. I am convinced that as part of Philips, we will be able to grow EPD and help many electrophysiologists and patients worldwide, as we aim to reduce procedure costs, simplify navigation and treatment, and ultimately improve procedure efficacy,” EPD Solutions founder & chair Shlomo Ben-Haim, who will stay on at Philips to help grow the business based on the acquisition, said in a prepared statement.

In May, Philips said it is joining with the American Heart Association and UPMC to launch a $30 million heart-focused collaborative venture capital fund.

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Abbott is developing a dual-chamber leadless pacer

Even before its acquisition by Abbott, St. Jude Medical had begun developing a dual-chamber leadless pacemaker, which would be a first if it succeeds.

Abbott and Medtronic are the only companies that have developed single-chamber leadless pacemakers; St. Jude recalled its version, Nanostim, in October 2017 after receiving 7 reports of lost telemetry and pacing output.

Get the rest of the story at our sister site, Medical Design & Outsourcing.

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FDA labels Medtronic Heartware recall as Class I

The FDA last Friday labeled a Medtronic (NYSE:MDT) voluntary select recall of its HeartWare HVAD systems over issues with unexpected power source switching as a Class I recall.

A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death.

The devices are being recalled over possible interruptions in the electrical connection between power sources, including batteries, adapters and the HVAD controller, which could cause disconnection and result in possible pump stoppage.

A pump stop event could cause issues including exacerbation of heart failure symptoms and other symptoms including mild weakness, dizziness, anxiety, nausea, loss of consciousness or death, according to an FDA release.

The interruption to the electrical system is caused by oxidation of the connecting surfaces between the power source connector and the controller’s power source socket, the FDA said.

The recall affects a total of 204,017 Medtronic devices, including the HeartWare device and accessories, manufactured and distributed between March 2006 and May 2018, according to an FDA notice.

The recall affects HeartWare controllers and controller kits with model numbers 1400, 1401, 1403, 1407 and 1420, HeartWare DC adapters with model numbers 1435 and 1440, AC Adapters with model numbers 1425 and 1430 and battery packs with model numbers 1650.

Medtronic said that the recall affects 16,399 implanted HeartWare HVAD devices as of May 22, and clarified that there have been no reports of serious harm related to the recall, calculating the per-patient probability of serious adverse events at approximately 0.003.

The Fridley, Minn.-based medtech giant began notifying clinicians of the issue last month, warning that the power disconnection could cause unexpected beeping which could confuse the patient or caregiver, as the unit’s controller may still display sufficient battery capacity or AC/DC connectivity while the beeping is active.

Medtronic suggested that clinicians managing HeartWare devices reiterate the importance of having two power sources connected at all times, to reinforce best practice guidance for managing power sources when going to sleep and awakening and instructing patients to report any unexpected audible tones.

Late last month, Medtronic said it made a lubricant solution designed to be applied to the HeartWare HVAD system’s power source connectors as a method for mitigating unexpected transient power switching, which will be distributed to Medtronic HearWare field reps, according to a press release.

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RenalGuard touts ADHF treatment feasibility study data

RenalGuard Solutions late last week released results from a feasibility study of its RenalGuard-guided diuretic therapy intended to improve fluid management in patients with acute decompensated heart failure and alleviate related symptoms.

Results from the study were presented at the European Society of Cardiology’s Heart Failure 2018 conference in Vienna, the Milford, Mass.-based company said.

The company said its RenalGuard-guided diuretic therapy is intended to allow for the use of an increased dose of diuretics without increasing the risk of diuretic resistant to allow for the safe and effective removal of excess fluids from ADHF patients, alongside alleviating certain symptoms.

A total of nine patients were evaluated in the feasibility study, with patients undergoing 24 hours of standard diuretic therapy with intravenous furosemide followed by 24 hours of diuretics in conjunction with its guided diuretic therapy.

Results indicated that patients in the experiment were able to achieve a safe rate of fluid loss through the induction of high urine rates, and that intravascular volume was maintained during treatment, the company said.

Study data also showed a significant improvement in breathing patterns and diuretic efficiency among RenalGuard patients, touting the creation of more than 2.5 times the amount of urine produced. The average change in estimated kidney function at 30 days post-treatment was reported as 8%, while three patients showed an increase of more than 25%, RenalGuard said.

“We are thrilled to reveal late-breaking data that demonstrates a promising step towards a new therapy for patients suffering from Acute Decompensated Heart Failure. RenalGuard-Guided Diuretic Therapy has the potential to establish a new front-line standard of care for heart failure patients, allowing physicians to maximize fluid removal while protecting patients from the potential negative impact of excessive fluid loss,” CEO Jim Dillon said in a press release.

In January, RenalGuard released results from a first-in-man feasibility study of its RenalGuard System designed to manage fluids during diuretic therapy to treat congestive heart failure in patients suffering from fluid overload.

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