Stimwave touts 6 month MIS SCS trial results

Stimwave updated logoStimwave today touted six-month data from a trial of its minimally invasive spinal cord stimulator system.

The company’s pivotal Surf trial compared a variety of waveform options without the need for separate trial devices. Stimwave reported that in the high and low frequency groups, back and leg pain responders were more than 92% and 86%, respectively.

The 100-patient study had 100% implant placement success, according to Stimwave, and no implant-related serious adverse events. Following a 30-day trial period with the implanted device and a six-month follow-up, participants experienced statistically significant improvement in VAS scores in both arms of the trial.

“Unique among neurostimulation systems, Stimwave has shown through this RCT the advantages of effectively utilizing wireless technology to deliver the proper dosing and programming versatility to pain suffers. In addition, using their wireless WaveCrest programming system, Stimwave can deliver a multitude of waveforms (low frequency, high frequency, tonic, and burst) to the same patient, using the same hardware, without the need for a separate trialing procedure to be performed. This allows the patient to cycle between waveforms, tailoring the stimulation to that individual patient,” CMO Dr. Andrea Trescot said in prepared remarks.

Stimwave also touted that the study results met or topped historical reported RCT studies with neurostim devices. Specifically, researchers reported sustainable VAS pain reduction in the active high-frequency group of more than 76% at the six-months endpoint.

“We are pleased with the positive results from the SURF study and thankful to all of the investigators and patients who participated in this important research,” co-founder & CEO Laura Tyler Perryman added. “We look forward to further exploring the various advantages of wireless power delivery and developing the body of evidence to enhance patient’s lives without excess burden, compilations and a lifetime of battery changes.”

The company’s Freedom SCS system is available in the U.S. with frequencies at or below 1,500 Hz. High-frequency stimulation with the Freedom SCS system is not available in the U.S., but it is cleared in Europe and Australia. The FDA is reviewing the safety and efficacy of the system’s high-frequency parameters.

In November last year, Stimwave won FDA 510(k) clearance for an Apple (NSDQ:AAPL) iOS device version of its WaveCrest Mobile platform patient controller application for pain management.

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Medtronic kicks off study for pain pump

Medtronic SychroMed II pain drug pumpMedtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids.

The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II pump as a viable alternative for people with chronic intractable non-malignant primary back pain.

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

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Cala Health launches trial for Cala Two neurostim device for essential tremor

Cala HealthCala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device.

The Burlingame, Calif.-based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor. The 500-patient, single-arm Prospect trial is designed to evaluate the Cala Two device for symptomatic relief for three months, with patients undergoing two daily treatments of 40 minutes each, separated by at least two hours.

Prospect’s primary outcomes include the subset score using the Tremor Research Group’s Essential Tremor Rating Assessment Scale, which rates six tasks from zero to four, with a higher score indicating more severe tremor; and the subset score using the Bain & Findley Activities of Daily Living, which rates eight tasks on the same 0-4 scale, according to Secondary outcomes include changes in kinematic measurements collected by Cala Two during postural holds. The study’s primary completion date is set for June, with an estimated completion date in September.

The first patients were enrolled in December 2018 at the University of South Florida Morsani College of Medicine in Tampa and USC’s Keck School of Medicine in Los Angeles, Cala Health said.

“People with essential tremor have their daily routine constantly disrupted and are looking for ways to control it,” Keck’s Dr. Mark Lew said in prepared remarks. “Our study aims to explore electrical stimulation via wearable therapy in the hopes of providing relief for those experiencing essential tremor.”

“The Prospect study will expand our understanding of patient benefit of CALA TWO by studying its therapeutic effect over a three-month period,” added Dr. Theresa Zesiewicz of the University of South Florida. “This therapy holds the promise to increase accessibility of an effective, non-invasive treatment option for hand tremors.”

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QT Vascular expands pivotal trial of Chocolate Touch DCB

QT Vascular updated logoQT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation.

The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy.

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

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Researchers question use of antibiotic shunts in hydrocephalus patients

Boston Children's Hospital - updated logoLed by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus.

Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess fluid and antibiotic shunts have become the standard of care in the U.S.

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

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Shockwave Medical launches U.S. pivotal for coronary lithotripsy

Shockwave MedicalShockwave Medical said today that it launched a U.S. pivotal trial for its coronary lithotripsy device, which is designed to prepare heavily calcified coronary lesions for stenting.

The technology uses sonic pressure waves to fracture intimal and medial calcium without damaging arterial tissue, Santa Clara, Calif.-based Shockwave said. Last April the Shockwave S4 catheter, designed to similarly treat peripheral arteries, won CE Mark approval in the European Union. The company raised $35 million in October 2017.

The two-year, 392-patient Disrupt CAD III study is designed to evaluate the safety and effectiveness of the Shockwave with the Shockwave C2 catheter in de novo, calcified, stenotic coronary arteries prior to stenting. The primary safety outcome is the rate of freedom at 30 days from major adverse cardiac events, defined as cardiac death, myocardial infarction or target vessel revascularization. The primary efficacy endpoint is the procedural success rate, defined as stent delivery with a residual stenosis of less than 50% and without in-hospital MACE, according to the company and

The estimated primary completion date is August 2020, with an estimated study close in July 2022. The co-principal investigators are Drs. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center and Jonathan Hill of London’s King’s College Hospital. The study’s chairman is Dr. Gregg Stone of New York’s Columbia University Medical Center. Disrupt CAD III’s first patient was enrolled last week by Dr. Richard Shlofmitz of Roslyn, N.Y.’s St. Francis Hospital.

“After previously using the peripheral IVL technology – Shockwave M5 – to enable transfemoral access for TAVR as well as for mechanical cardiac support and hearing the enthusiasm from Europe about coronary IVL, we are very excited to investigate the clinical potential of the coronary technology in the United States,” Kereiakes said in prepared remarks. “This therapy holds tremendous potential from a safety perspective for patients and an ease of use perspective for physicians – if coronary IVL is shown to be safe and effective, it could be a game changer for the way we treat calcified arteries today.”

“Having treated nearly 100 patients with IVL since its European launch, the benefits for treating complex patients are evident. I am delighted to be a part of this important global trial to introduce my U.S. interventional colleagues to this novel technology. IVL is easy to use and has been a huge advancement for our management of calcified lesions,” Hill added. “I think U.S. interventionalists will recognize the simplicity and ease of use of the IVL system and will appreciate its ability to be rapidly deployed in any cath lab. I have no doubt that IVL is poised to become the key differentiating technology compared to other calcium modification tools.”

Last month Abiomed (NSDQ:ABMD) revealed plans to invest $15 million in Shockwave and collaborate on a training and education program in the U.S. and Germany.

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Gynesonics touts 1-year pivotal IDE Sonata trial data


Gynesonics yesterday released 12 month results from the FDA investigational device exemption pivotal trial of its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids.

Results from the trial were published in the journal Obstetrics and Gynecology, the Redwood City, Calif.-based company said.

The company’s flagship Sonata System is a uterus preserving, incision-free uterine fibroid treatment designed to treat fibroids transcervically with radiofrequency energy. The system combines both an intrauterine ultrasound system with a proprietary radiofrequency ablation device, Gynesonics added.

“It is exciting to have the final one-year results from the Sonata Pivotal IDE Trial published in Obstetrics and Gynecology. We are appreciative of the investigators and their commitment to advancing options in women’s healthcare by studying the outcomes of our technology for the treatment of symptomatic uterine fibroids in the Sonata Trial. This is an important milestone and it comes on the heels of our recently announced substantial equity financing. We will continue to invest in high quality clinical and health economic outcomes research to help ensure access to the Sonata treatment for women suffering from symptomatic uterine fibroids in the United States and globally,” prez & CEO Christopher Owens said in prepared remarks.

In the 147-patient Sonata trial, investigators explored the use of the Sonata system at 21 outpatient sites in the U.S. and a single site in Mexico.

Data from the trial indicated that 99% of patients in the trial required no surgical reinterventions for heavy menstrual bleeding, with 97% reporting satisfaction with the treatment, the company said. Symptom improvement was reported by 96% of patients, with 95% reporting a reduction in menstrual bleeding. A total of 65% of patients in the trial reported at least a 50% reduction in menstrual bleeding.

The mean length of stay for patients, including procedure time, was reported as 2.5±1.2 hours, with 50% of patients returning to normal activity the next day. No device-related adverse events were reported, Gynesonics said.

“Uterine fibroids are a common problem that reduce the quality of life for women in the United States today. The Sonata pivotal clinical trial outcomes, along with the data from other published clinical outcome studies using the same technology, support offering sonography-guided transcervical uterine fibroid ablation as a treatment option to appropriate patients suffering from symptomatic uterine fibroids. This transcervical, uterine sparing approach avoids some of the risks of other treatment options, with minimal disruption in our patients’ lives,” study lead author Dr. Scott Chudnoff of Stamford Health said in a prepared statement.

“Publication of our pivotal clinical trial results in the prominent journal, Obstetrics and Gynecology, will help us raise awareness among gynecologists, the broader women’s healthcare community, and private insurers about the risk-benefit profile of treating symptomatic uterine fibroids in appropriate patients using the Sonata system. Publication in this excellent journal also supports the quality of the clinical trial design and the robustness of the one-year outcomes. Taken together, our current and future clinical trial publications are designed to strongly support the clinical value of the Sonata system, as we seek insurance coverage and begin commercialization,” board chair Karen Talmadge said in a press release.

Earlier this month, Gynesonics said that it closed a $75 million equity financing round to support its Sonata system.

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SightGlass Vision launches trial for pediatric myopia-controlling eyeglasses

SightGlass Vision

Opthalmalogical device maker SightGlass Vision said yesterday that it launched a pivotal clinical trial exploring the use of its novel lenses designed to reduce the rate of progression in children between six and nine years old.

The Palo Alto, Calif.-based company’s Cypress trial is a multicenter, double-blinded, randomized controlled clinical trial that aims to enroll 255 patients across 14 clinical sites in the U.S. and Canada. The primary endpoint of the trial is the progression of myopia over 36 months, the company said.

SightGlass Visions’s lenses are intended to reduce the progression of myopia, something the company said is not provided by current technologies on the market, which only correct for myopia.

“Although some people view myopia as an ordinary, often unavoidable condition, it has been well established that it often progresses rapidly during childhood. This results in the need for stronger prescription glasses and increases the risk of potentially blinding conditions such as glaucoma and retinal detachment in adulthood. We are pleased to be part of the Cypress program to study SightGlass’s novel lenses which could help revolutionize myopia care,” principal investgiator Katie Gilbert-Spear said in a press release.

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Report: Medtronic, Boston Scientific stand by paclitaxel-eluting devices despite JAHA study

Medtronic, Boston Scientific

Major medtech players Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate, according to a Star Tribune report.

In the meta-analysis, researchers led by Dr. Konstantinos Katsanos analyzed data from 28 trials involving paclitaxel-coated devices used in the femoral and/or popliteal artery. Data from the trial indicated a 68% relative increase in all-cause mortality risk with paclitaxel-coated devices after two years and a 93% relative increase after five years when compared to therapy with uncoated devices.

Results from the trial were published in the Journal of the American Heart Association in December.

Executives from both companies spoke at the J.P. Morgan Healthcare Conference in San Francisco suggesting that their own data does not support the higher death rates noted in the new study, according to the Star Tribune.

Read the whole story on our sister site, Drug Delivery Business News

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Hancock Jaffe sets endpoints for FIH VenoValve study

Hancock Jaffe Labs

Hancock Jaffe Laboratories (NSDQ:HJLI) today announced the endpoints for its planned first-in-human study of its VenoValve device.

The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said.

Endpoints for the study include improvements in reflux time measured by duplex scans and rVCSS, VAS and VEINES scores, which are used as clinical measurements for venous disease. Hancock Jaffe said that patients in the trial will be monitored at regular intervals, with a focus on 90 and 180 day results.

The company has already won clearance in Colombia to launch the trial, looking to enroll five to 10 patients with severe chronic venous insufficiency.

“We have already received more than 100 inquiries from patients in Colombia wanting to participate in our study. Patients will be carefully screened under the supervision of Dr. Jorge Hernando Ulloa, our primary investigator in Bogota, and Dr. Marc H. Glickman, Hancock Jaffe’s chief medical officer.  Because results from the study will come relatively quickly, now is the appropriate time to begin to explain the terminology that we will be using to measure our success,” CEO Robert Berman said in a press release.

Hancock Jaffe said that data from the trial will be used to make design modifications to the VenoValve in preparation for a pivotal trial of the device in the U.S

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