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Meddevicetracker Weekly Roundup

March 12-16, 2018


March 12, 2018



V-Wave Presents First-In-Human Study Results at ACC 2018


Early and late results from the First-In-Human study of the V-Wave System were presented during a late-breaking clinical trial session in a presentation titled "Interatrial Shunting for Treating Heart Failure: Early and Late Results of the First-in-Human Experience With the V-Wave Interatrial Shunt System" at the American College of Cardiology (ACC) Annual Meeting on March 12, 2018 in Orlando, FL.


Data summarized in this event is solely based on data contained in the abstract from the ACC abstract website. Sagient was unable to obtain updated data, if any, from the actual presentation at the ACC conference.


This was a prospective single-arm, multi-center cohort study including heart failure (HF) patients with reduced and preserved ejection fraction (HFrEF/HFpEF), who remained in New York Heart Association (NYHA) Class III/IV despite of optimal medical/device therapy. Shunt were implanted following transseptal catheterization with transesophageal echocardiography (TEE) guidance under general anesthesia. Patients had clinical, hemodynamic and echocardiography evaluations at baseline and at 12 months, and yearly thereafter.


Primary endpoints were procedural success and device/procedure-related major cardiovascular events at 3- and 12-month follow-up. Secondary endpoints were clinical and hemodynamic parameters at follow-up (exploratory efficacy).


38 patients (mean age: 66±9 years, 92% men, 79% with HRrEF -mean EF: 26±7%-) were enrolled in 6 centers. The device was successfully implanted with no periprocedural death in all patients (procedural success: 100%); and 1 patient (2.6%) had a procedure-related cardiac tamponade treated with pericardiocentesis. There were no device-related adverse events. At 12-month follow-up, improvements were seen in NYHA Class (p<0.001), quality-of-life (p<0.001), and 6-minute walk distance (p=0.03). There were no significant changes in hemodynamic parameters at follow-up. 12-month TEE (n=34) showed shunt occlusion in 5 patients (14.7%), and shunt stenosis >50% in 13 patients (38%). After a median follow-up of 26 (18-48) months, 10 patients (26.3%) died and 12 patients (31.6%) were rehospitalized due to HF. Patients with patent non-stenotic shunt exhibited better hemodynamic parameters (p=0.01 for wedge pressure) and had a lower risk of death or HF rehospitalization (18% vs 53%, p=0.02).


This first experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical outcomes in patients with HFrEF and HFpEF. Shunt stenosis or occlusion associated with poorer hemodynamic and clinical outcomes.

See more about the V-Wave Shunt on Meddevicetracker.


Cogentix Medical Enters into Merger Agreement with LABORIE Medical Technologies


Cogentix Medical announced that it has entered into a definitive merger agreement under which Laborie Medical Technologies (LABORIE) will acquire all of the outstanding shares of Cogentix Medical for a total consideration of approximately $239 million. Under the terms of the definitive merger agreement, LABORIE (through its wholly-owned subsidiaries LM US Parent, Inc. (Parent) and Camden Merger Sub, Inc. (Merger Sub) will commence a tender offer for all outstanding shares of Cogentix Medical common stock for $3.85 per share in cash. The offer of $3.85 per share in cash represents a premium of 28 percent over the average closing price of Cogentix Medical common stock over the last thirty days. Cogentix Medical currently anticipates the transaction will close in the first half of the second quarter of 2018. Upon completion of the transaction, Cogentix Medical will become a wholly owned subsidiary of LABORIE.


Accelmed Growth Partners LP and Mr. Lewis Pell, who collectively beneficially own shares representing approximately 60% of Cogentix Medical's outstanding common stock, have entered into tender and support agreements in favor of Parent and Merger Sub, pursuant to which those stockholders, among other things, will agree to tender all of their shares of Cogentix Medical common stock beneficially owned by them to Merger Sub in response to the tender offer, as well as restrictive covenant agreements in favor of Parent and Merger Sub.


Under the terms of the merger agreement, following the successful completion of the tender offer, the transaction will be completed by a second-step merger in which all outstanding shares of Cogentix Medical common stock not tendered in the tender offer will be converted into the right to receive $3.85 per share of common stock, in cash. Closing of the tender offer and merger is subject to certain customary conditions, including the tender in the tender offer of more than 50 percent of all outstanding shares of Cogentix Medical common stock. The transaction is also subject to other customary closing conditions.


See more about Cogentix Medical and LABORIE Medical Technologies on Meddevicetracker.



March 13, 2018



Reflow Medical Announces Initiation of Wing-IT IDE Clinical Trial


Reflow Medical announced that the first patients have been enrolled in a prospective, multi-center, non-randomized, investigational device exemption (IDE) study intended to evaluate the ability of the Reflow Wingman Catheters to cross chronic total occlusions (CTOs) in peripheral lesions.


Initial patient enrollments were performed by Nilesh Goswami, MD, of Prairie Cardiovascular at HSHS St. John’s Hospital Prairie Heart Institute, Springfield, Illinois, and S. Jay Mathews, MD, of Bradenton Cardiology Center in Bradenton, Florida.


The Wing-IT trial is expected to enroll 85 patients at up to 13 centers in the United States and Europe. The principal investigator for the study is John Laird, MD, of Adventist Heart and Vascular Institute, St. Helena, California


See more about the Wingman Crossing Catheter on Meddevicetracker.



United Health Products Receives CE Mark Approval for HemoStyp


United Health Products announced that it has obtained Class III and CE mark approval for HemoStyp in the European Economic Area (EEA). The EEA comprises the 28 European Union members and a number of other countries. HemoStyp is approved for use in internal surgical procedures in more than 30 countries.


The approval was received following the provision of all required documentation by the relevant regulatory agencies. The CE marking certifies that a product has met EEA health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the EEA and abroad must meet CE marking requirements where applicable to market their products in Europe. A manufacturer who has gone through the conformity assessment process may affix the CE mark to its product.


See more about HemoStyp on Meddevicetracker.



March 14, 2018



Glooko Announces Results of Pilot Program with Sharp Rees-Stealy Medical Group


Glooko announced the results of its pilot program with Sharp Rees-Stealy Medical Group that aimed to optimize data-driven decisions for Type II Diabetes patients with high A1c levels. The six-month program revealed improvements in average blood glucose levels, patient adherence and engagement.


The initial pilot program focused on 50 people with Type II Diabetes with an A1c >10%. The teams tracked patient engagement and Advanced Perfect Care (APC) measures including A1c, LDL, microalbumin (MALB), or Neph Screen and blood pressure before, during and after the pilot. The pilot ran for six months, from April through October 2016.


Physicians and case managers identified and referred the patients. Case managers met with the pilot group in the clinics to train them on Glooko; case managers then used Glooko to monitor their patients’ progress in between appointments. Data was synced from glucose meters using Glooko’s MeterSync Blue, featuring Bluetooth technology.


Once patients were using Glooko, case managers used a risk-stratified view of the patient population in the Glooko Population Tracker (Glooko’s web app). Having on-demand access to reports and insights about food intake, medication and activity levels enabled case managers to more easily engage in personalized, teachable moments with patients. Case managers conducted monthly follow-up calls with patients to review blood glucose trends and discuss medication and lifestyle adjustments, so patients could learn to more effectively manage their diabetes.


Patient engagement was very strong throughout the pilot – patients doubled their daily BG testing frequency from less than one time per day to an average of 1.8 times per day over 14 weeks. As Glooko syncs data (including historical data) directly from the BG meter, determining the impact Glooko has on testing frequency can be determined without the need to rely on self-reported data, which can be subject to error. Blood glucose testing has been correlated with improved glycemic control, so this increase is a positive leading indicator for improved clinical outcomes.


Patients also showed strong engagement with the Glooko app and steadily increased their use of the app by more than 4x towards the end of the pilot, with an average patient engaging with Glooko approximately 20 times per month.


In addition, a patient survey showed that more than 80% of patients reported their experience with Glooko as being very good or good. Clinical outcomes from the pilot were positive. Patients who were adherent with the program experienced improvements in APC: A1c and compliance in completing two A1c tests.


Patients who used Glooko experienced improvements in average blood glucose (BG) over time, which drove the A1c improvements indicated above. At the start of the pilot, the patients in the population had an average BG of 160 mg/dL; by the end of the six-month pilot, patients in the population improved their average BG by ~15 mg/dL (~10%). Those who continued to use Glooko beyond the pilot period continued to see improvements, with patients achieving an average BG of 136 mg/dL nine to twelve months post-pilot.


Sharp Rees-Stealy assessed several different solutions that monitored patients’ glucose data remotely and ultimately selected Glooko because of its broad diabetes device support, easy-to-use mobile app, and collaborative approach. Due to the positive patient engagement and clinical outcomes results, Sharp Rees-Stealy is expanding to a second phase with Glooko, which will draw insights from the first phase and broaden the group of patients.

See more about the Glooko Mobile Insulin Dosing System on Meddevicetracker.



K2M Launches YUKON OCT Spinal System at AANS/CNS 2018


K2M Group Holdings announced the commercial launch of the YUKON OCT Spinal System at the 34th Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS), occurring March 14-17 in Orlando, FL (Booth #200). At the meeting, the Company will also showcase Balance ACS or (BACS), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for spine patients.


The YUKON OCT Spinal System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in August 2017, was developed to help surgeons restore cervical sagittal balance through posterior fixation in the occipito-cervico-thoracic regions of the spine. It features a newly designed top-loading polyaxial screw with high angulation and the ability to accommodate rods in two diameters. The screw provides 60 degrees of angulation for 60 degrees of coronal swing “60 for 60” to aid in screw placement, providing up to 105 degrees of polyaxial angulation.


YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium to accommodate construct rigidity based on degenerative or deformity corrections. The system’s reduction instruments allow for intraoperative flexibility and ease of use. A Pistol Grip Rod Reducer provides up to 20 mm of reduction, while the Sequential Reducers deliver up to 15 mm of controlled reduction and correction.


BACS provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.


See more about the YUKON OCT Spinal System on Meddevicetracker.


Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft


Cerapedics announced the company received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of P-15L Peptide Enhanced Bone Graft compared to autograft in transforaminal lumbar interbody fusion (TLIF) surgery for degenerative disk disease.


Spinal fusion procedures such as TLIF involve joining and stabilizing one or more vertebrae to reduce pain and nerve irritation. A bone graft, which has historically been obtained from the patient’s pelvis, is placed in the interbody space to promote fusion. P-15L Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation, and is designed to be used as a substitute for autologous bone.


The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include 364 patients with degenerative disk disease at up to 30 clinical trial sites across the U.S. Patients will be assessed prior to surgery and six weeks, three months, 12 months, and 24 months post-surgery. The primary endpoint for the study is composite clinical success at 24 months based on several factors including the achievement of radiographic fusion (assessed by CT), at least a 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit, and no subsequent surgical intervention at the index level. Clinical investigators are permitted to use any FDA cleared static PEEK interbody device and any FDA cleared pedicle fixation system delivered through either an open or minimally invasive TLIF technique.


In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures. The company will be initiating enrollment in the newly approved TLIF IDE study with the expectation that the results from the study will support a PMA application.


See more about i-FACTOR on Meddevicetracker.



March 15, 2018



Johnson & Johnson Announces Patient Enrollment Completion for U.S. IDE Study


Johnson & Johnson announced that Biosense Webster has completed patient enrollment in its U.S. Investigational Device Exemption (IDE) study of the THERMOCOOL SMARTTOUCH SF Catheter. The prospective, multicenter, non-randomized study of 367 patients is evaluating the device for the treatment of persistent atrial fibrillation (AF), an irregular heartbeat that lasts beyond seven days.


The THERMOCOOL SMARTTOUCH SF Catheter was launched in 2016 in the United States to treat symptomatic, drug-refractory, paroxysmal AF, an intermittent AF that resolves within a week. The device combines contact force technology and a porous tip to optimize efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, which eases the fluid management process.


See more about the ThermoCool Diagnostic/Abalation Catheter on Meddevicetracker.

Organogenesis Launches New PuraPly Antimicrobial Small Size


Organogenesis announced its PuraPly Antimicrobial (AM) wound management product is now available in a new 1.6 cm disc size.


PuraPly and PuraPly AM are both U.S. Food and Drug Administration (FDA) 510(k)-cleared Class II medical devices indicated for acute and chronic wound management across a wide variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, and venous and diabetic ulcers. Both products are available in a range of sizes to meet the needs of a variety of wound types.


PuraPly AM utilizes a novel technology—purified native collagen matrix embedded with polyhexamethylene biguanide, or PHMB, a broad-spectrum antimicrobial. This combination of native collagen and PHMB helps manage the reformation of biofilm while supporting healing across a wide variety of wound types, regardless of severity or duration.


See more about PuraPly on Meddevicetracker.



March 16, 2018



Johnson & Johnson Announces Binding Offer from Platinum Equity to Acquire Lifescan Diabetes Business


Novo Nordisk announced that the European Commission (EC) has granted Johnson & Johnson announced that it has received a binding offer from Platinum Equity, a private investment firm, to acquire its LifeScan business for approximately $2.1 billion, subject to customary adjustments. 

LifeScan markets blood glucose monitoring systems for home and hospital use under the global brand OneTouch. The OneTouch portfolio includes personal blood glucose meters, testing strips, lancets, point of care testing systems and integrated digital solutions. 

The acceptance period for the offer will end on June 15, 2018, unless extended, and during that time, consultations with relevant works councils are planned. If the offer is accepted, the transaction would be expected to close by the end of 2018, subject to the satisfaction of customary closing conditions.


See more about Johnson & Johnson on Meddevicetracker.



Foundation Medicine Pursues Regulatory Approval for FoundationOne CDx in Japan


Foundation Medicine announced that Chugai Pharmaceutical, a member of the Roche Group, will broaden patient access to Foundation Medicine's comprehensive genomic profiling (CGP) services for individuals with advanced cancer. Specifically, Chugai has filed for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for FoundationOne CDx, which, if approved in Japan, would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan. Chugai will also lead commercial efforts in Japan for Foundation Medicine's suite of CGP assays.

FoundationOne CDx is the first FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics. If approved in Japan by the MHLW, Chugai will be the Marketing Authorization Holder of FoundationOne CDx in Japan.

FoundationOne CDx assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is indicated for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. The first FDA-approved test of its kind for all solid tumors, FoundationOne CDx is a diagnostic test that acts as: a broad companion diagnostic for patients who may benefit from treatment with specific FDA-approved targeted therapies; a CGP test that includes genomic biomarkers such as microsatellite instability (MSI) and tumor mutational burden (TMB), to help inform the use of other targeted oncology therapies, including immunotherapies; a tool for physicians that identifies patient opportunities for clinical trial participation; and, an FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics. 


See more about FoundationOne on Meddevicetracker.


Intezyne Partners with Exosome Diagnsotics on IT-139 Companion Diagnostic


Intezyne announced that it has partnered with Exosome Diagnostics to design and validate an assay for use in Intezyne's upcoming Phase 1/2 clinical trials of IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies. Intezyne's IT-139 is a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies. IT-139 successfully completed a Phase 1 monotherapy study and was granted an Orphan Drug Designation (ODD) in pancreatic cancer. Additional ODDs are expected in the next 18 months. Intezyne is currently manufacturing IT-139 and expects to initiate one or more combination Phase 1/2 studies by early 2019.


See more about the IT-139 Companion Diagnostic on Meddevicetracker.

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