Hancock Jaffe launches first-in-human VenoValve study

February 19, 2019 By Fink Densford Leave a Comment

Hancock Jaffe Laboratories (NSDQ:HJLI) said today that it launched the first-in-human study of its VenoValve device, touting its successful implantation in the first subject in the study.

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.

Hancock Jaffe said that the first patient in the Bogota, Colombia-based trial was walking a day after surgery and that the VenoValve appears to “be functioning as it should” with no early signs of thrombosis, reflux or other adverse events.

The trial aims to enroll an initial 5 to 10 patients with severe, deep venous chronic venous insufficiency. Patients in the trial will be implanted with the VenoValve and monitored out to six months with duplex scans to measure reflux time.

Endpoints for the study, which were announced last month, 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.

“We are so excited to get our VenoValve study underway and are thrilled that the first patient is doing so well. We will continue to monitor the patient for the next few weeks and then proceed with additional VenoValve implantations,” CEO Robert Berman said in a press release.

Hancock Jaffe said it plans to release preliminary data from the first group of VenoValve recipients during the second quarter of 2019, with patients continuing to be monitored out to six months.

Registration is Open for DeviceTalks Boston

Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.

REGISTER NOW

Carbon debuts dental technology platform
3D printing company Carbon unveiled an integrated technology platform for the dental market last week at the International Dental Show in Cologne, Germany. The platform combines software, hardware and materials in an end-to-end solution designed to meet the needs of dental and orthodontic labs and enable them to scale quickly and economically, according to the… […]
This drug sponge could reduce cancer treatment side effects
Researchers from the University of California Berkeley have developed sponges that, when injected into the bloodstream, can absorb excess drugs. The drug sponge is made from an absorbent polymer coating and is 3D printed to precisely fit veins that carry the blood flowing out of a targeted organ. The sponge could then absorb any leftover… […]
Nyxoah sleep apnea nerve-stim therapy gains CE Mark
Nyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA). The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure… […]
Ex-NuVasive CEO Lucier to head new M&A firm Corza Health
Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets. Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and… […]
Steute Meditech touts medical-grade foot switches
Steute Meditech has launched a new line of wireless, medical-grade foot switches. The wireless switches operate on 2.4 GHz by using spread-spectrum frequency-hopping technology. They are also designed for medical applications with a number of safety functions that allow for the operation of several wireless systems in one transmission zone. Steute Meditech’s new foot switch… […]
Gottlieb wants to fix clinical trials before departing FDA
The FDA has issued new draft guidance to protect human subjects of clinical trials and the data these trials generate. The draft guidance on using a risk-based approach to conducting clinical trials is one of a handful of guidances promulgated by the agency since FDA commissioner Dr. Scott Gottlieb announced his upcoming departure. In a… […]
Toray touts polymer for regenerative medicine
Toray Industries (Tokyo) recently announced that it has created a novel bioabsorbable polymer with skin-like flexibility. Proprietary functional polymer design technology allows the polymer to recover its original shape even after being stretched 10 times the original length, the company explained in a March 14 announcement. Toray also has identified a way to improve the… […]
Thornhill Medical’s ‘simple’ device may save lives
Thornhill Medical’s device to help patients suffering from carbon monoxide poisoning has won de novo clearance from the FDA. Carbon monoxide poisoning occurs when carbon monoxide attaches to the hemoglobin in the blood exactly where oxygen is supposed to attach, reducing the amount of oxygen carried to the brain and other tissues. Toronto-based Thornhill Medical’s… […]
Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. DeviceTalks is excited to announce that Tyler Shultz will be the closing keynote speaker at DeviceTalks Boston. Shultz will take attendees behind the story that everyone… […]
Study shows catheter ablation for Afib significantly boosts quality of life
Patients who had catheter ablation for atrial fibrillation (Afib) had fewer symptoms, a significant long-term improvement in quality of life and fewer recurrences and hospitalizations than those who received drug therapy alone, according to a government-funded study. The same study showed that catheter ablation appeared no more effective than drugs in preventing strokes, deaths, and… […]
Medical device cybersecurity: It’s time to get real
Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough? Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One… […]