Boston Scientific to acquire Apama Medical in deal worth up to $300m

Boston Scientific, Apama Medical

Boston Scientific (NYSE:BSX) said today it inked a deal worth up to $300 million to acquire Apama Medical and its radiofrequency balloon catheter system designed to treat atrial fibrillation.

The deal includes an initial $175 million in cash up-front from Marlborough, Mass.-based Boston Scientific and an additional $125 million in contingent payments between 2018 and 2020 based on clinical and regulatory milestones. Boston Scientific expects the acquisition to close the 4th quarter of 2017.

Campbell, Calif.-based Apama’s novel RF balloon is a single-shot, multi-electrode device designed to combine the benefits of RF point-by-point and balloon-based ablation approaches, the company said, claiming the system delivers differentiated energy levels and shorter procedure times.

The system features an incorporated digital camera with LED lights and sensing electrodes for real-time visualization of the procedure and catheter electrode contact.

“The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialization, would broaden our portfolio of differentiated arrhythmia solutions. We are also excited about the ability to integrate the Apama RF balloon system with our Rhythmia HDx mapping system to provide physicians with an unprecedented visualization of the heart during ablation procedures,” Boston Scientific rhythm management prez Joe Fitzgerald said in a prepared statement.

Results from the 1st-in-human study of the device showed the Apama RF balloon met safety and efficacy endpoints and achieved successful pulmonary vein isolation in treating paroxysmal AF patients.

“Study results reinforce the Apama RF balloon is an advancement in single-shot technology for PVI and can provide physicians with greater control and efficiency when performing AF ablations. We look forward to continuing the development and commercialization of this novel ablation solution to treat both paroxysmal and persistent AF,” Boston Scientific rhythm management and global health policy chief medical officer Dr. Kenneth Stein said in a press release.

The Apama RF balloon is currently being studied in clinical trials in Europe as the company looks to achieve CE Mark approval, which it hopes to receive in late 2018.

Boston Scientific said the acquisition is expected to be immaterial to its adjusted earnings per share for 2017 and 2018, and more dilutive on a GAAP basis due to amoritization expense, transaction and integration related costs.

Last November, Apama Medical said it raised a total of $19.7 million, with $13.2 million coming from a closed Series C round and $6.5 million from a debt facility with Silicon Valley Bank.

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How Boston Scientific is boosting medical device value

Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life.

The idea is to help health providers quickly grasp the benefits of Boston Sci’s longer lasting EnduraLife battery technology, which the company touts has nine clinical studies and eight years of real-world data to back up its abilities.

“We used to do those [battery life] calculations in-house … for physicians who are interested. … We decided, ‘Why not let the truth be free?’” said Ken Stein, SVP and CMO for rhythm management and global health policy at Boston Sci.

Read the whole story on our sister site, Medical Design & Outsourcing

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Apple to partner with American Well, Stanford to launch heart arrhythmia trial with Apple Watch 3

Apple (NSDQ:AAPL) said this week it will partner with telemedicine company American Well and Stanford University to test the performance of its Series 3 Apple Watch to detect heart arrhythmias, according to a Fortune report.

The tech giant announced the Apple Heart Study at its iPhone unveiling event earlier this week, saying that the company would seek to use the watch as a replacement for traditional heart sensors, according to the report.

The new watch comes with an improved heart rate monitor which Apple claims will collect data including post-workout recovery heart rate and abnormal spikes in heart rate while resting, Fortune reports.

Though the company didn’t reveal any new health-related innovations on its most recent iPhone 8 and iPhone X release announcement, CEO Tim Cook said the company is still focused on the healthcare industry.

The tech giant has recently made strides towards making its iPhone devices healthcare-connected central depositories, announcing in June it would team with Health Gorilla to add health and diagnostic lab data and with DexCom to integrate G5 CGM support into its Apple Watch, alongside rumors that the company was looking to acquire Aetnahealth.

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LivaNova mulls sale for CRM biz

LivaNova (NSDQ:LIVN) said today that it’s considering a sale for its cardiac rhythm management business, tapping Barclays to shop the $250 million operation to potential buyers.

“As part of our ongoing efforts to position LivaNova for long-term success, we are sharpening our focus on the company’s areas of strength and market leadership. To that end, we are exploring options to realize the full value of the CRM Business Franchise,” CEO Damien McDonald said in prepare remarks. “The CRM business franchise is a global business and strong regional player with attractive assets, a robust pipeline and growth potential; however, it is no longer a strategic fit within LivaNova’s portfolio. The board and executive leadership team are committed to driving value for shareholders and customers and will continue to take actions that strengthen LivaNova’s position as a leading, innovative medical device company dedicated to extending and improving the lives of patients around the world.”

LivaNova’s CRM business put up sales of $249.1 million last year, the company said, adding that “there can be no assurances that the process of exploring strategic options for the CRM business franchise to maximize shareholder value will result in a transaction or that any transaction will be consummated.”

“The company has not set a timeline for completion of the review process, and it does not intend to disclose further developments unless or until a definitive decision has been reached by the company or the company has otherwise determined that further disclosure is appropriate or required,” LivaNova said.

LivaNova was formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015.

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LivaNova heater-cooler implicated in infections in 12 pediatric heart surgery patients

A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report.

A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients with infections identified through phone calls to families.

A number of patients who have only received phone calls are slated to see doctors this week, leaving the possibility that the numbers will grow, STAT reports.

The hospital has since replaced the contaminated machine, according to the report.

An investigation began after 3 incision infections were reported within 72 hours in patients who had undergone heart surgeries at the hospital, STAT reports.

“We were able to jump on this pretty quickly. We surveil our patients pretty intensely, and when we had several patients present (symptoms) within a 72-hour period, that set off a red flag right away,” hospital chief medical officer John Heaton told The New Orleans Advocate.

The hospital is paying for treatment of the infections and their related costs, according to STAT News, and has switched from using tap water to filtered water in a new heater-cooler made by a different company.

In February, LivaNova released a field safety notice it sent to customers with its FlexTherm heater cooler device informing them it is voluntarily removing all such devices installed at customer sites over design issues.

Last October, the U.S. Centers for Disease Control & Prevention warned of the risk of serious bacterial infection in open heart surgery patients patients from a device made by Sorin, which merged last year with Cyberonics to form LivaNova.

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Corindus launches post-approval study for CorPath GRX robot-assisted PCI

Corindus Vascular Robotics (OTC:CVRS) announced the first patient enrollment in a post-market study of its second-generation CorPath GRX System, a robot-assisted system for percutaneous coronary interventions such as stenting.

“Enrollment of the first patient in the Precision GRX registry is a major milestone for the company and we look forward to the participation of leading centers across the country,” president & CEO Mark Toland said in a press release. “We strongly believe that the improvements to the CorPath platform with GRX will further validate the widespread benefits and adoption of robotic-assisted PCI.”

Get the full story at our sister site, The Robot Report.

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7 medtech stories we missed this week: August 11, 2017

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From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention.

1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant

Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally mature. It is supposed to be used with spinal fixation systems like Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.

2. Life Spine touts first use of TiBow spacer

Life Spine has announced the first clinical use of its TiBow MIS TLIF Expandable Spacer System with Osseo Loc Surface Technology in an Aug. 8 press release. TiBow is designed for in-situ expansion for increased endplate coverage and stability for minimally invasive TLIF and oblique approaches. It gives the surgeon the ability to restore sagittal alignment.

3. Cardiac Science inks deal to supply AEDs to Philadelphia schools

Cardiac Science announced in an Aug. 8 press release that it has reached a deal with the School District of Philadelphia to make automated external defibrillators (AEDs) available in all 220 Philadelphia schools. Philadelphia’s high schools and middle schools already have the Cardiac Science Powerheart G3 and G5 AEDs in place and the elementary schools are set to receive the company’s Powerheart G5 units.

4. ApiFix wins nod in Australia

ApiFix has received TGA certification through its Orthotech Pty. distributor to market the ApiFix system in Australia, according to an Aug. 8 press release. The ApiFix system is designed to treat and correct adolescent idiopathic scoliosis (AIS) using a minimally-invasive surgical approach. The system is a non-fusion spinal implant system that is designed to improve the quality of life of patients who have to have scoliosis surgery.

5. Pentax Medical launches slim linear ultrasound

Pentax Medical announced in an Aug. 9 press release that it has launched its new Slim Linear Ultrasound Endoscope in the U.S. The endoscope features a smaller insertion tube, a smaller distal end and a shorter bending section to help endoscopies see and reach hard-to-access anatomy.

6. Hip Innovation launches clinical trial of novel hip replacement system

Hip Innovation Technology has started its clinical trial to evaluate the effectiveness and safety of the HRS lead hip replacement system, according to an Aug. 9 press release. The clinical study will include 100-120 patients who are scheduled to receive a total hip arthroplasty. The company plans to test effectiveness using clinical radiologic, radiostereometric and patient-reported outcomes. It will measure safety through collecting device-related adverse events. They will also assess the quality of life of each patient.

7. Varian Medical inks distribution deal with Bionix radiation therapy

Varian medical Systems announced in an Aug. 9 press release that it has entered an agreement with Bionix Radiation Therapy to distribute the Bionix brachytherapy applicators in North America. Varian has agreed to market the Bionix Esophageal Application (E-App) and the Anorectal Applicator (AR-1). E-App is a disposable brachytherapy applicator that is designed to treat upper GI cancers. It has five independently operated balloons that help maintain the central position of source catheters in straight and curved anatomy. AR-1 is a disposable brachytherapy applicator that is designed to treat anal and rectal cancers. It allows for exophytic tumors to press closer to a source catheter to deliver a very high dose to the tumor while keeping healthy tissues safe.

Here’s what we missed last week.

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SteadyMed tops Q2 sales, EPS estimates

Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates.

The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth of 239.4% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

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FDA approves new Cardiovascular Systems saline pump after recall

Cardiovascular SystemsCardiovascular Systems (NSDQ:CSII) said yesterday that it plans to have a saline infusion pump on the market this summer to replace the pump it recalled last month, now that the FDA granted pre-market approval for the new pump.

The pumps are used to provide saline and lubricant during orbital atherectomies with CSI’s Diamondback 360 device. The St. Paul, Minn.-based company pulled roughly 900 of the pumps April 17 after finding that electromagnetic interference in hospitals can cause them to switch to standby mode. There were no reports of patient injury, CSI said, and customers can continue to use the older models until the newer versions are available.

“The company anticipates replacing all recalled units by no later than August 31, 2017,” CSI said.

The pumps were sold between April 7, 2015 and April 4 of this year. The recall is expected to deliver a $1.5 million charge during CSI’s fiscal 3rd quarter.

Yesterday the company met expectations on Wall Street with its 3rd quarter results, posting losses of $1.7 million, or 5¢ per share, on sales of $52.1 million. CEO Scott Ward said the recall is likely to be “moderately disruptive” during the fiscal 4th quarter, when the CSI expects to report net losses of -6¢ to -4¢ per share on sales of $51.5 million to $52.5 million.

AtriCure’s Q1 numbers top estimates

AtricureAtriCure (NSDQ:ATRC) beat the consensus forecast at both the top and bottom lines with its 1st-quarter results, sending share prices up 3% today.

Losses for the Mason, Ohio-based medical device company rose4.7% to -$10.2 million, or -32¢ per share, on sales growth of 14.8% for the 3 months ended March 31. Analysts on Wall Street were looking for losses of -35¢ on sales of $40.3 million.

The news sent ATRC shares up 3.0% to $21.30 apiece today in early trading.

“During the 1st quarter of 2017, we made significant progress across our strategic priorities, achieving solid results in our base open business while driving forward our transformation into the minimally invasive market,” president & CEO Mike Carrel said in prepared remarks. “We are advancing our clinical trials meaningfully with several new sites enrolling for Converge and expect enrollment to accelerate in the 2nd half of the year. We are looking forward to continued momentum across our business throughout 2017.”

AtriCure said it still expects to post losses of -94¢ to $1.04 per share this year, on constant-currency sales of $175 million to $178 million.