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

[Image from unsplash.com]

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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Fractyl Labs launches Revita DMR diabetic treatment study

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Fractyl

Fractyl Laboratories said today it launched the Revita-2 clinical trial of its Revita DMR procedure in orally-treated type 2 diabetes patients with poorly controlled disease.

The company said that it has enrolled the 1st patient in the trial at a European center participating in the study.

The Revita DMR is a minimally invasive procedure designed to ablate and ‘rejuvenate’ the duodenum (the 1st part of the intestine) in order to alter glucose metabolism, the Lexington, Mass.-based company said.

“Untreated insulin resistance can lead to more severe diseases including fatty liver disease and NASH. The initial clinical data of Revita DMR is encouraging, and there is enormous need for treatments that can change the course of these metabolic diseases,” Jacques Devière of Brussels’ Hôpital Erasme said in a prepared statement.

The Revita-2 clinical trial is a randomized, sham-controlled, blinded study at multiple centers in Europe and will include 3-month glycemic and hepatic endpoints, the company said.

“The clinical data we have gathered to-date suggests Revita DMR may address a significant unmet medical need, which is the underlying insulin resistance in patients with type 2 diabetes who are poorly controlled despite medications. We anticipate that the Revita-2 trial will further build the clinical support about the safety and efficacy of the Revita DMR procedure and inform the design of additional clinical trials,” co-founder & CEO Dr. Harith Rajagopalan said in a press release.

Novartis’ Ultibro Breezhaler tops corticosteroid for COPD in head-to-head study

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NovartisNovartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts.

The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients regardless of eosiophil count. These results contrast with previous work suggesting better outcomes with inhaled corticosteroids for patients with high eosinophil counts.

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

Symic Bio raises $30m for peripheral vein graft failure therapy

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Symic BioSymic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures.

Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, SB-061.

The San Francisco-based company also said yesterday that it plans to launch a Phase III trial of SB-030 in 2018, following a pre-investigational new drug meeting with the FDA. Supported by interim results from the Phase I/IIa Shield study, the regulatory watchdog recommended that the company move forward with a single Phase III registration study.

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

Anika touts Phase III data for Cingal knee therapy

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  • Philips, ResMed tout collaborative home ventilation therapy COPD study results

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    Philips, ResMed

    Royal Philips (NYSE:PHG) and ResMed (NYSE:RMD) today touted results from a collaboratively-supported clinical trial exploring the use of home noninvasive ventilation with oxygen therapy on patients with chronic obstructive pulmonary disorder, which indicated improved survivability and prolonged time to readmission.

    Results from the study were published today in the Journal of the American Medical Association.

    “Patients with severe COPD and persistent hypercapnia have historically had limited therapy options available to them and outcomes have generally been poor. The trial suggests that combining home oxygen and home non-invasive ventilation therapy can reduce hospital readmissions while maintaining patients’ quality of life, which will drastically change the way we approach COPD treatment worldwide. We are looking forward to hopefully decreasing the mortality and readmission rates that result from severe COPD with further research,” Dr. Nicholas Hart of London’s St Thomas’ Hospital said in a prepared statement.

    The 116-patient, 12-month study aimed to explore the effect home non-invasive ventilation and oxygen therapy had on time to readmission or time to death in patients with persistent hypercapnia after an acute COPD exacerbation, compared to those treated with home oxygen therapy alone.

    A total of 64 patients in the trial completed the 12-month study period, with a median time to readmission or death of 4.3 months for those treated with home NIV and oxygen therapy versus 1.4 months for those on home oxygen alone, according to study results.

    For patients treated with home NIV and oxygen therapy, the 12-month risk of readmission or death was 63.4%, with patients treated with home oxygen therapy alone at 80.4%.

    After 12 months, 16 patients in the home NIV and oxygen therapy had died, versus 19 in the home oxygen therapy only group, according to study results.

    “This study shows that home non-invasive ventilation is a potent, therapeutic tool that clinicians can use to help keep patients with advanced COPD out of the hospital. We hope that this will, in turn, allow them to lead healthier and more active lives at home. These findings add considerably to our knowledge of this highly prevalent and debilitating respiratory disorder, and are expected to greatly influence how clinicians care for patients with COPD on long-term oxygen therapy,” Philips chief medical liaison Dr. Teofilo Lee-Chiong Jr. said in a press release.

    “This trial adds decisively to the growing body of evidence supporting the broader use of non-invasive ventilation for patients with COPD. Just knowing NIV can help cut re-hospitalization or death risk in half is a game changer,” ResMed chief medical officer Dr. Carlos Nunez said in a prepared statement.

    CytoSorbents touts Refresh trial study data

    CytosorbentsCytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

    Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.

    The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.

    The prospective, randomized trial looked to evaluate the safety and feasibility of the CytoSorb in treating deadly inflammation in critically-ill and cardiac surgery patients between 18 and 80 years.

    Results from the study indicate that valve replacement surgery was the highest risk procedure for peak plasma free hemoglobin, and that treatment with the CytoSorb increased reductions in peak pfHb levels by 26% at 3.5 hours and 38% at 4 hours. Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery, according to CytoSorbents

    The company said that the trial achieved its primary safety endpoint with a favorable adjudication of all serious adverse events, and no significant differences in the rate of adverse events or serious adverse events at 30 days. No unanticipated adverse device effects were reported.

    “We are pleased to report on this first multi-center U.S. trial demonstrating the safe and easily implemented use of CytoSorb during high risk complex cardiac surgery.  Inflammation and toxic injury from excessive plasma free hemoglobin and activated complement are well-known insults that are associated with organ injury such as acute kidney injury, stroke, lung injury, and other complications.  The finding that complex valve replacement procedures generate high levels of pfHb, and that CytoSorb can significantly reduce pfHb and activated complement in this population, represents a potentially important advance in the field.  In a future larger study, we plan to correlate the reduction of pfHb and activated complement in this enriched at-risk population with reduced organ dysfunction and injury, while confirming the risk/benefit of the therapy,” principal investigator Dr. Joseph Zwischenberge of the University of Kentucky College of Medicine said in a press release.

    In January, CytoSorbents and  Fresenius Medical Care (NYSE:FMS) said that they expanded the terms of their partnership and added a co-marketing agreement for the CytoSorb blood absorber in countries where the therapy is available.

    InVivo says 2 Inspire patients reverted to original injury scale, posts solid Q1

    InVivo Therapeutics

    InVivo Therapeutics (NSDQ:NVIV) this week said that 2 neuro spinal scaffold trial patients who had reportedly improved have reverted to their original injury state. The company also released 1st quarter earnings which beat the Street, but still saw shares fall.

    The company said that a patient it had announced in January had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury was recently assessed to have reverted back to a complete AIS A spinal cord injury.

    A separate patient, which the company said in March had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury, was recently assessed to have been reverted back to a complete AIS A spinal cord injury.

    “The AIS grade improvement rate observed thus far in the Inspire study compares favorably to the natural history of spinal cord injury. We look forward to monitoring these patients’ progress as they reach the primary endpoint at six months post-injury and as we work towards completing enrollment of Inspire,” CEO & chair Mark Perrin said in a press release.

    The company said that of the 14 patients in the Inspire trial, 8 have reached the study’s 6-month primary endpoint, with 5 of those having received an AIS grade improvement compared to baseline.

    The Cambridge, Mass.-based company posted losses of $6.4 million, or 21¢ per share, seeing losses grow 3.5%. Losses per share came in just under the consensus on Wall Street, where analysts had expected to see losses of 22¢ per share.

    “In the 1st quarter, we continued to make significant progress at InVivo and with the Inspire study. By early April, we had enrolled four new patients into the Inspire study, with three patients enrolled within 30 days of each other. We also announced four new clinical sites for the Inspire study,” CEO Mark Perrin said in a prepared statement.

    Shares in InVivo dropped today nearly 15%, down 50¢ at $2.90 at close.