Abiomed puts $15m into Shockwave

Shockwave's S4 Lithotripsy CathAbiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies.

Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The company said its catheter is often used in patients with heavily calcified Iliac arteries in order to prepare for the delivery of devices with catheters, like transcatheter heart valves and Abiomed’s Impella heart pump.

“While we are still early in our commercial scaling both in the US and Europe, I am pleased with how positively our Shockwave technology has been received and how many different types of patients and vessels our customers are able to safely treat with our IVL system,” Shockwave’s president & CEO Doug Godshall said in prepared remarks.

“We are delighted to be able to offer patients our solution in combination with Abiomed’s Impella technology using a minimally invasive approach, which should meaningfully improve outcomes. With Abiomed’s best-in-class approach to training and education, Shockwave will be able to more efficiently increase awareness and introduce IVL to customers, which we believe will help them better treat their most challenging patients.  We are encouraged to see the positive clinical response we have witnessed to date,” Godshall added.

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Judge guts plaintiff’s case in 2nd Cook Medical IVC bellwether

Cook Medical LogoAn Indiana judge last week gutted the plaintiff’s case in the second bellwether trial in the multi-district litigation brought over Cook Medical‘s inferior vena cava filters.

Tonya Brand sued Cook in 2014, alleging that the Celect IVC filter implanted prior to a spine procedure fragmented, sending the broken pieces into her thigh and near her spine. Her lawsuit included claims for  strict liability and negligent failure to warn, strict liability and negligent design defect, negligent manufacturing, negligence per se, breach of warranty, loss of consortium, and punitive damages. Cook filed for summary judgment, seeking to have the case dismissed.

But testimony from the surgeon who implanted the Celect device in Brand, Dr. Mark Rheudasil, indicated that he wouldn’t have treated Brand any differently, Judge Richard Young of the U.S. District Court for Southern Indiana wrote, according to court documents.

“The undisputed evidence reflects that Dr. Rheudasil (1) did not rely on the Celect 4 IVC filter’s [instructions for use], (2) already knew at the time of plaintiff’s implant about all of the complications plaintiff experienced, and (3) would not have treated plaintiff any differently even knowing now the complications that she actually suffered. Therefore, plaintiff is unable, as a matter of law, to establish causation in her strict liability and negligent failure to warn claims,” Young wrote.

Brand also failed to respond to Cook’s summary judgment bids to strike her breach of warranty, negligent manufacturing and loss of consortium claims, which Young also dismissed. That leaves only her strict liability and negligent design defect and negligence per se claims intact.

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How Reggie Groves reinvented Medtronic’s atrial fibrillation biz

Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview:

When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about the medical device industry. That was by design, she told MassDevice – the company was looking for somebody outside of the medtech world to launch their CareLink Network. It was the world’s first remote monitoring system designed to link the data in patients’ implanted devices with physicians.

Reggie Groves“I knew that (Medtronic) was a big company that was well respected and that was about all I really knew about them,” she said. “I saw what they were doing in remote device check as the start of a complete transformation of the medical device industry – moving away from being the implant to being the data managers.”

After commercializing CareLink and then moving to the regulatory and quality side of the business, Groves stepped up to build Medtronic’s atrial fibrillation ablation business. At the time, according to Groves, Johnson & Johnson (NYSE:JNJ) held a sizable lead in the AF space, followed by St. Jude.

Medtronic’s AF unit “basically didn’t exist,” Groves said – the company had previously sold its electrophysiology business. It was Groves’ job to determine how the company could build an AF division that would stand out among fierce competition.

Catch Groves’ keynote interview at DeviceTalks West on Dec. 11 – register today!

She decided to rethink the way that the company’s sales force was selling its newest technologies to electrophysiologists.

“Most companies would have said, ‘We’ve got this great big sales force, here’s another product in their tool bag. Give it to them and let them sell it.’ And I said, ‘That’s the worst thing we could do because it’s a disruptive technology and we don’t want every customer to have it.’ If you’re the sales rep who’s also selling CRT devices and ICT devices, you’re going to bundle,” she said. “Something is going to be given away and the easiest thing to give away is the new novel thing. You’ll never make any money in AF, which is why Medtronic walked away from it the first time.”

Groves set up her own sales team and told them to only sell Medtronic’s AF technology to early adopters.

“When you walk in the door for the sales meeting, if you get the ‘Oh, it’s too expensive, oh it’s not flexible enough, oh it doesn’t do enough,’ – turn around and walk out the door. That’s not an early adopter. You need to find the customers who get the value proposition,” she explained.

At the time, competitive devices from St. Jude and J&J were designed to allow the very best doctors to perform an ablation anywhere in the heart. At Medtronic, Groves was positioning the company’s AF device as usable by any electrophysiologist who was looking to isolate the pulmonary vein.

Her plan was not without pushback, according to Groves.

“It wasn’t easy, even within Medtronic. I had lots of naysayers and it took the CEO stepping in, listening to the argument and making the call,” she said. “But I got really lucky that I believed in a different approach to launching a product compared to most big companies and Medtronic let me do it my way.”

Don’t miss out on the rest of Groves’ exciting story – see her at DeviceTalks West on Dec. 11-12.

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Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy

Reva MedicalReva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy.

The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer.

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

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Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold

OrsiroIn a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority.

The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. The results were first presented earlier this year at the 2018 Transcatheter Cardiovascular Therapeutics meeting.

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

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J&J’s Biosense Webster launches Heliostar multi-electrode ablation cath trial

J&J's Biosense Webster multi-electrode catheterJohnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study.

The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation.

The Heliostar device features 10 electrodes and is designed to allow electrophysiologists to achieve pulmonary vein isolation with a single application of RF energy, according to Biosense Webster.

Cardiac electrophysiologists Drs. Rodney Horton and Andrea Natale treated the first patient in the Stellar study at the Texas Cardiac Arrhythmia Institute.

“This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins,” Dr. Horton said in prepared remarks.

“The Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and, most importantly, shorter procedure times. Heliostar is an exciting technology and we look forward to seeing the final study results,” Dr. Natale added.

“The Stellar study is an important step forward in expanding treatment options for atrial fibrillation patients in the United States,” Uri Yaron, worldwide president of Biosense Webster, said. “The burden of atrial fibrillation on quality of life, morbidity and mortality is significant and we are committed to developing innovative and life-enhancing technologies that fill important clinical needs, improve care and reduce this burden.”

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Amsel Medical wins FDA nod for Endo Occluder

Amsel Medical

Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures.

The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices.

The Amsel Endo Occluder is a mechanical occlusion clip delivered through a fine needle intended to be deployed to transfix a target vessel while clamping it shut. The device is composed of an endoscopic litigating clip applier and clips which the company said are intended or use on tubular structures or vessels.

“We are thrilled to expand the Amsel Occluder family of single-use, site-specific vascular control devices into the endoscopic and minimally invasive surgery market with this recent Pre-Marketing Notification (510(k)) by the US Food and Drug Administration. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel or duct. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder device is cleared for commercial distribution,” founder & prez Dr. Arnold Miller said in a press release.

Last November, Amsel Medical touted the first-in-human clinical use of its Amsel AOD2 occluder device, which took place at the NYU Langone Medical Center in New York.

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Cultivate(MD) buys into Medical Ingenuities and its PH Band hemostasis device

Genesis Innovation Group's Cultivate(MD)

Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said yesterday that it has invested in radial artery occlusion device developer Medical Ingenuities.

Wheaton, Ill.-based Medical Ingenuities is developing the PH Band, a novel radial artery occlusion device intended to for patent hemostasis.

“We are proud to announce that we just closed an investment from Genesis Innovation Group’s Cultivate(MD) fund.  These funds will allow Medical Ingenuities to continue the regulatory process, required validation and testing to file our FDA submission in early 2019. We are excited to partner with Genesis Innovation Group as they are experienced medical device business operators with whom we can also partner for the commercialization of the PH Band,” Medical Ingenuities CEO Chip Corrigan said in a prepared release.

The PH Band is designed to provide real-time feedback to clinicians monitoring radial artery patency to prevent radial artery occlusion, the company said. The device is also designed to reduce nurse workload and occlusion-related complications.

“At Cultivate(MD), we are always seeking technologies with the potential to be disruptive in their segment of medical devices.  We believe we have found another one with Medical Ingenuities’ innovative approach to the rapidly expanding field of radial artery catheterization.  With strong intellectual property protection and experienced leadership in this segment, we look forward to their new Patent Hemostasis Band becoming the industry standard,” Genesis Innovation Group R&D VP Don Running said in a press release.

Last November, Genesis Innovation Group said that it formed the Cultivate(MD) Capital Fund, which looks to manage $10 million to invest in early stage healthcare companies with a focus on medical device and orthopedic technologies.

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Hancock Jaffe clears Colombian regulatory hurdle for VenoValve trial

Hancock Jaffe Labs

Hancock Jaffe Laboratories (NSDQ:HJLI) said today that Colombia’s INVIMA, the country’s FDA equivalent, completed their review of the company’s application for a first-in-human trial of its VenoValve, clearing another hurdle towards launching 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 that the next step is to present an official application for approval of the trial from INVIMA’s Medical Device and Other Technologies Committee at a meeting next month.

“Dr. Marc Glickman, our senior vice president and chief medical officer, will travel to Bogota at the beginning of December to begin site initiation, and surgical training for implantation of the VenoValve. Dr. Glickman has overseen many successful clinical trials, and will work closely with our Colombian partners to attend to all details leading up to the VenoValve implantations,” CEO Robert Berman said in a press release.

Upon approval, Hancock Jaffe said that it will begin patient enrollment immediately for the first-in-human trial and will make arrangements to export the VenoValve devices, which have already been manufactured and inspected, to Colombia. The company plans to announced the dates for the first implantations in the trial shortly.

In August, Hancock Jeffe said that it won approval from Colombia’s Medical Research Committee at Fundación Santa Fe de Bogotá to launch the trial.

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Boston Scientific offers $4B for BTG

Boston Scientific acquires BTGBoston Scientific (NYSE:BSX) said today that it agreed to offer roughly $4.24 billion to acquire British medical device maker BTG (LON:BTG).

The £8.40-per-share offer, worth about £3.3 billion, is a 36.6% premium over BTG’s closing price yesterday and a 51.0% premium over the stock’s 90-day volume-weighted average price, the London-based company said. BTG’s largest division makes devices for oncology and vascular conditions; the company also makes overdose and antivenin drugs for snakebite.

“The acquisition of BTG and its rapidly growing peripheral interventional portfolio is an exciting extension of our category leadership strategy that will augment our capabilities in important areas of unmet need such as cancer and pulmonary embolism,” chairman & CEO Mike Mahoney said in prepared remarks. “We are confident that the addition of these therapies to our portfolio will ultimately advance patient care in ways that could not be realized by either company alone, while also allowing us to realize substantial revenue and cost synergies and provide a strong return for investors.”

“I would like to thank and acknowledge all BTG colleagues for building a leading global healthcare company. Our interventional medicine portfolio delivers value to patients and is a significant growth driver for the business, and we’re also proud of our highly profitable pharmaceuticals business focused on critical care products,” added BTG CEO Dame Louise Makin. “We remain committed to transforming patient care through our passion for people, relentless curiosity, and ambition to lead the way. Boston Scientific shares that vision, and their comprehensive clinical and commercial expertise will accelerate the delivery of our strategy and expand the global reach of our interventional medicine portfolio. The strong strategic and cultural fit between the companies gives me confidence that our business will continue to make a real difference for our patients, customers, employees and wider stakeholders.”

Marlborough, Mass.-based Boston said it plans to fund the deal, expected to close in the first half of 2019, with cash and debt. It’s forecast to add 2¢ to 3¢ to the company’s adjusted EPS next year and increasing thereafter.

BTG shares were up 34.0% to £8.24 apiece today in late-morning trading in London. BSX shares closed down -5.2% at $35.29 apiece yesterday.

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