7 medtech stories we missed this week: Sept. 29, 2017

medtech missed

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From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. EOI wins FDA nod for FLXfit15 expandable cage

EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance will help enhance the company’s FLXfir 3D expandable cage system and help expand the surgeon’s flexibility and capability by offering different length options.

2. ivWatch inks distribution deal with Terumo

ivWatch has recently signed a licensing and distribution agreement with Terumo to improve patient safety, according to a Sept. 21 press release. Terumo will become the exclusive distributor of the ivWatch Model 400 and ivWatch OEM board in Japan. ivWatch technology can be integrated with other patient monitoring systems, infusion pumps and other devices easily with the ivWatch OEM board. The agreement also allows Terumo to exclusively integrate ivWatch into existing and future Terumo products in Japan.

3. FDA clears Mortise Medical’s LigaMetrics suture anchor system

Mortise Medical announced in a Sept. 26 press release that it has received FDA 510(k) clearance for its LigaMetrics Suture Anchor System. The LigaMetrics Suture Anchor System is the first and only knotless suture anchor that allows for precise, measured tension control of the suture repair construct. The system is designed to connect to and lock suture tape that is attached to soft tissue or a conventional suture anchor.

4. Lombard Medical launches Aorfix delivery device in Japan

Lombard Medical has commercially launched its new delivery system for the Aorfix AAA system, according to a Sept. 26 press release. The new delivery system is marketed in Japan by Medico’s Hirata and is used to deliver Lombard’s Aorfix AAA stent graph.

5. FDA expands clearance for Cefaly migraine device

Cefaly announced in a Sept. 21 press release that the FDA has expanded its clearance for Cefaly Acute migraine treatment. The device is used for the acute treatment of migraines in patients 18 years or older. The Cefaly Acute allows migraine sufferers to use the device during a migraine attack which makes it more than a preventative measure.

6. Varian touts first use of Halcyon oncology system

Varian Medical System has announced that the first patient in the world has been treated using Varian’s Halcyon system, according to a Sept. 21 press release. The patient had head and neck cancer. The system is suited to offer advanced treatments for prostate, breast, head and neck and other forms of cancer.

7. Sanuwave inks JV deal with Brazil’s Mundimed

Sanuwave announced in a Sept. 28 press release that it has signed a joint venture agreement with Mundimed in Brazil. The agreement states that the companies will split profits in the wound care industry while using the dermaPACE technology. The net present value is expected to exceed $25M. Sanuwave will also receive an undisclosed amount of cash payments beginning Sept. 30 and the payments will continue through 2019.

Here’s what we missed last week.

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Humacyte lands $14m to expand uses for human acellular vessel

Humacyte wins expedited review designation for acellular vesselHumacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis.

The Research Triangle Park, N.C.-based company said it plans to evaluate Humacyl as a conduit for hemodialysis in a group of patients with end-stage renal disease who need renal replacement therapy.

“This significant and incremental investment from CIRM further validates the potential of our bioengineered human acellular vessel’s capabilities as a more durable and safe vascular access option for patients requiring dialysis treatment,” CMO Dr. Jeffrey Lawson said in prepared remarks.

“Based on the early promising signals from our Phase II study results published in The Lancet last year, and the positive data that we expect from our ongoing Phase III trials comparing the Humacyl to ePTFE grafts, we envision broader opportunities for Humacyl beyond an alternative to synthetic grafts, starting with this newest study comparing our product to arteriovenous fistulas.”

Humacyte said it expects results from its pivotal Humanity trial later next year. From there, it hopes to submit a biological license application to the FDA for its human acellular vessel.

Earlier this year, Humacyte won the regenerative medicine advanced therapy designation from the FDA, helping to speed up the development and review of Humacyl.

“CIRM recognizes the challenges faced by more than 465,000 patients in the U.S. undergoing hemodialysis procedures with few effective vascular access options available to them, and we deeply appreciate this significant support,” chairman & CEO Carrie Cox added.

“This additional funding enables Humacyte to explore the use of our innovative technology to treat a broader range of patients suffering from ESRD that need hemodialysis as a life-saving treatment. With Humacyl, we hope to realize our vision to provide better healthcare options for patients through a more durable, biological alternative, while lowering the costly and deadly risk of infection and higher rates of abandonment of current synthetic alternatives.”

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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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Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data

Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair.

The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease.

Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its existing global sales force in other regions.

“JLL is our exclusive distributor in Japan, and it has done an outstanding job supporting physicians and capturing market share in Japan with our AFX device for the treatment of abdominal aortic aneurysms. We are currently working with JLL on a full market release of our AFX2 bifurcated endograft system in Japan after receiving approval for that device earlier this year. We also anticipate Japanese market launches of Ovation and Nellix in the future. These new agreements with JLL will expand our relationship to include thoracic devices and enable us to provide a complete range of endovascular aortic devices to physicians worldwide,” Endologix CEO John McDermott said in a prepared statement.

Endologix also released data from its 1st-in-human experience from the 1st 7 patients treated with the Ovation Alto. The devices were implanted at Auckland, New Zealand’s Auckland City Hospital between Aug. 2017 and Feb. 2017.

Results from the initial cases indicated successful delivery and deployment in all patients with a 100% technical success rate. No type I or type III endoleaks, stent graft migrations, abdominal aortic aneurysm ruptures, abdominal aneurysm-related deaths or secondary interventions were reported.

“Although limited to only 7 patients, early experience with the Ovation Alto was promising and suggests the device may safely expand EVAR indications beyond that of other available devices,” Dr. Sean Lynden, who presented the results at the VIVA 2017 conference wrote in a summary.

Endologix touted that the device features a low-profile 15-F outer diameter delivery system and the ability to seal at the level of the proximal sealing ring, which is 7-mm distal to the top of the fabric.

Last month, Endologix touted results from its Leopard clinical trial, which compared its AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.

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Medtronic touts 5-year gendered sub-analysis data from Endurant AAA stent graft trial

Medtronic (NYSE:MDT) today released new 5-year data from a gender separated subset of the Engage trial of its Endurant II abdominal aortic aneurysm stent graft system.

The subset analysis aimed to compare results across both male and female patients. Fridley, Minn.-based Medtronic said that historically, women have had worse EVAR outcomes than men due to anatomy differences, including more angulated aortic necks and smaller aneurysms and iliac vessels.

The analysis included 1,263 patients, with 133 female and 1,130 males. For women in the study, data indicated a 99.2% rate of successful delivery and eployment, only 0.3% lower than the 99.5% reported in men. Freedom from aneurysm-related mortalities in females were reported at 100%, slightly ahead of the 97.5% rate reported for men.

Type Ia endoleaks were reported in 3.8% of females, lower than the 1.3% rate reported in males. Freedom from secondary procedures between men and women were similar, at 84.1% and 85.6%, respectively. Stabiliziation or decreases in aneurysm sacs were nearly identical, at 89.6% for females and 89.4% for males, according to the data.

Women reportedly had a 100% rate of freedom from rupture, versus a lower 98.4% rate in men.

“It is well known in the clinical community that women have not benefitted to the same extent as men when receiving an EVAR procedure, and in turn, have become a greatly underserved patient population. Endurant is now the only stent graft system to close the outcomes gap between men and women at 30 days, one year, and five years, which sets a new benchmark for EVAR device performance and has the potential to change the treatment paradigm for female patients,” Dr. Marc Schermerhorn of Boston’s Beth Israel Deaconess Medical Center said in a prepared statement.

Medtronic touted the Engage trial as the “most robust post-market registry ever initiated in the study of EVAR,” and said the trial will continue to gather evidence of the real-world patient population.

“Our objective has always been to deliver proven, durable solutions that effectively address varying patient anatomies and yield long-term clinical outcomes. The newly presented clinical evidence from Engage truly underscores this objective and validates that Endurant is able to deliver similar technical and long-term clinical outcomes between genders through five years, despite significantly challenging female anatomy,” aortic biz GM & VP Daveen Chopra said in a press release.

Yesterday, Medtronic said it launched its StealthStation ENT surgical navigation system designed for otolaryngology procedures.

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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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PQ Bypass touts subset analysis data from Detour system trial

PQ Bypass today released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days.

The data was presented today at the Vascular InterVentional Advances conference, the Sunnyvale, Calif.-based company said.

Results came from a 6-month subset analysis of 50 patients who underwent percutaneous treatment of femoropopliteal blockages with lengths between 25 cm and 45 cm, the company said. PQ Bypass said it was sucessfully able to treat the blockages without “significant impact on venous health.”

Primary patency at 6 months was reported at 88.9% with optimal placement, and a primary patency of 76.9% was reported overall. Rutherford Class improvements of at least 2 grades were reported in 92% of patients, with significant improvements in ankle brachial index and no impact on venous function reported, the company said.

“Patients with long segment femoropopliteal blockages are in need of advanced therapeutic alternatives to existing treatments. While endovascular revascularization is effective in shorter lesions, its durability in longer segment blockages has not matched that of open surgery. Fully percutaneous bypass is designed to combine the durability advantages of surgical bypass with the minimally invasive advantages of a percutaneous procedure. The outcomes we are seeing in the Detour I trial indicate that a fully percutaneous bypass procedure has potential to fill this gap in treatment options,” Cleveland Clinic Vascular Surgery dept. chair Dr. Sean Lyden said in a prepared statement.

The PQ Detour procedure is a fully-percutaneous femoral-popliteal bypass procedure which uses fluoroscopic guidance to deploy Torus stent grafts from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery through 2 independent anastomoses.

PQ Bypass’ Torus stent graft is an expanded polytetrafluoroethylene-covered self-expanding nitinol stent designed to improve blood flow in patients with symptomatic peripheral artery disease in superficial femoral artery de novo and restenotic TASC II C and D lesions.

“PQ Bypass has long been committed to addressing the need for value-based, patient-centered advancements in PAD that help minimize trauma, reduce length of stay and improve recovery times, while also providing a safe and effective clinical solution for these patients who are in need. These data demonstrate the potential of the Detour procedure in extremely long SFA lesions. We look forward to continuing our path toward regulatory approval with Detour II, a pivotal trial that we anticipate initiating by the end of this year,” board chair Richard Ferrari said in a press release.

In March, PQ Bypass said it won CE Mark approval for 3 devices designed to treat patients with superficial femoral artery lesions due to peripheral artery disease.

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Study: Esophageal surgeries with robotic platforms safe and effective

Transchiatal esophagectomy procedures utilizing robotic platforms are “effective and safe” for carefully selected patients, according to a new study from Allina Health hospitals.

The robotic technology platforms can provide operating surgeons with better views during surgery and allow lymph nodes to be removed without additional incisions, according to the study.

Results from the study, which it touts to be the largest of it’s kind, were published in the journal Diseases of the Esophagus.

Data from the 100-patient study indicated that robotic-assisted transhiatal esophagectomy procedures were effective and safe with acceptable operative times, minimal blood loss, standard postoperative morbidity and adequate progression free and overall survival profiles.

Median operative time was 264 minutes, while median estimated blood loss was recorded at 75 mL. The median intensive care stay for patients undergoing RATE procedures was 1 day, with a medial hospital stay of 8 days. The most common postoperative complications were nonmalignant pleural effusion at 38% and recurrent laryngeal nerve injury at 33%. Thirty-day mortality in the trial was 2%.

The median number of lymph nodes removed was 17, with R0 resection being achieved in 97.8% of patients. At the end of the median follow-up period of 27.7 months, median PFS was 41 months, while median OS was 54 months, according to the study. One-year and 3-year PFS rates were 82% and 53% respectively.

“Very few centers have adopted robots for this procedure because of the technical difficulties and unique skills that are needed by the surgeons and the operating room staff. But the robotic arms can turn and twist and reach more places than human hands will ever be able to,” former Allina surgeon and study principal investigator Dr. Daniel Dunn said in a press release.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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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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Cardiovascular Systems touts 1-year, sub-analysis data from Liberty PVI study

Cardiovascular Systems (NSDQ:CSII) today released both 1-year and a sub-analysis results from the Liberty 360 clinical trial of peripheral interventions, including those using its DiamondBack 360 coronary orbital atherectomy system.

The 1,200 patient study aimed to evaluate acute and long-term clinical outcomes of peripheral interventions for patients with peripheral artery disease, with the most common device used being the company’s Diamondback 360, the St. Paul, Minn.-based company said.

1-year outcomes were presented at the 2017 Amputation Prevention Symposium in Chicago by Dr. Jihad Mustapha of Michigan’s Metro Health Hospital.

“Our commitment to clinical rigor is key to our success and growth plans. The Liberty 360 study continues to reinforce the importance of endovascular intervention for this difficult-to-treat patient population, with a particular focus on amputation prevention for patients with PAD, and specifically critical limb ischemia,” prez & CEO Scott Ward said in a press release.

Results from the trial indicated that at 12 months, individuals with critical limb ischemia spanning Rutherford Classifications between 4 and 5 had a 96% freedom from amputation, while those with an RC6 rating had an 81.7% freedom from amputation. Data also indicated that CLI patients had improvements in RC, wound healing and quality of life.

“Liberty 360 represents as close to a real-world experience as possible with various endovascular strategies across Rutherford Classes. Following endovascular intervention, we saw a marked improvement across all Rutherford Classes at one year, as well as high freedom from major adverse events. In particular, Liberty 360 provides new, compelling evidence that PVI can lead to amputation free survival in CLI patients and serves as a patient-centric alternative to primary amputation,” Dr. Mustapha said in a prepared release.

In its sub-analysis, Cardiovascular Solutions examined freedom from major adverse events and major amputation for patients treated with its Diamondback 360 device.

Results from the sub-analysis indicated that patients treated with the Diamondback reported statistically similar major adverse event outcomes at 12 months for patients with RC 4-6 patients, and high freedom from major amputations across all Rutherford classes.

Cardiovascular Systems said that patients receiving vessel preparation with the Diamondback prior to drug-coated balloon therapy reported a 95.2% rate of freedom from major adverse events at 12 months with no major amputations.

“These findings show that patients treated with our innovative orbital atherectomy device experienced positive clinical outcomes such as high freedom from major adverse events and freedom from major amputation. It further validates OAS as an effective treatment option for patients suffering from severe forms of PAD,” CEO Scott Ward said in a prepared statement.

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