Showing all posts written by Rick Park
According to a June 28, 2017 press release, Dutch healthcare company Philips has agreed to buy Colorado Springs-based Spectranetics Corporation, a cardiac device manufacturer, for approximately 1.9 billion euros ($2.16 billion), inclusive of Spectranetics’ cash and debt. Philips states in the press release that the acquisition of Spectranetics will expand and strengthen Philips’ Image-Guided Therapy Business Group. According to the press release, Spectranetics is growing at a double-digit percentage rate and expects sales this year of around $300 million.
According to Spectranetics‘ website, its products include laser atherectomy catheters for treatment of arterial blockages with laser energy. In addition, Spectranetics produces drug-covered balloons to treat blockages. Philips stated that the drug-covered balloons are a key growth driver in Spectranetics’ portfolio. According to Philips, Stellarex drug-coated balloon is CE-marked and under review by the U.S. Food and Drug Administration (FDA) for premarket approval.
According to the press release, Philips is offering Spectranetics shareholders $38.50 in cash per share, which is a 27 percent premium to the closing price of the Spectranetics shares on June 27. According to Bloomberg, Philips also will buy back as much as 1.5 billion euros ($1.7 billion) of its own stock starting in the third quarter, and the share buyback program will run for two years.
The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016.
Premarket notification (510(k)) is one of several alternative procedures that medical device manufacturers must undergo before being able to market their medical devices intended for human use. The 510(k) notification is required for medical devices that do not need to receive premarket approval (PMA) from the FDA and are not exempt from the 510(k) requirement. The FDA explains that medical devices are classified into three classes (Classes I, II, and III) based on based on the level of control necessary to assure the safety and effectiveness of the device. Most Class I and II devices and a few Class III are subject to the 510(k) requirement. Although a 510(k) applicant does not need to provide scientific evidence of safety and effectiveness for the intended use of its device, the applicant must demonstrate that the device is at least as safe and effective (“substantially equivalent”) to a legally marketed device (“predicate device”).
The FDA may exempt devices from 510(k) requirement. A list of factors that the FDA use to determine whether the device is exempt from 510(k) requirements includes: (1) whether the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) whether characteristics of the device necessary for its safe and effective performance are well established; (3) whether changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely to result in the device’s classification.
Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amended sections 510(l) and 510(m) of the FD&C Act require the FDA to publish any Class I and Class II devices that the FDA determines no longer require premarket notifications under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. The FDA is required to publish initial lists for Class II devices and Class I devices within 90 days and 120 days, respectively, after the enactment of the 21st Century Cures Act and then to update the lists at least once every 5 years.
A list of 510(k)-exempt Class I devices is expected to be published in about 30 days.
Sanofi, a French multinational pharmaceutical company, and Verily Life Sciences LLC (formerly Google Life Sciences), Alphabet’s U.S.-based company devoted to the study of life sciences, recently announced the launch of Onduo, a joint venture created through collaboration between the two companies in diabetes treatment. Bloomberg and Reuters reported that Sanofi is inventing $248 million in the joint venture, and Verily the equivalent amount.
According to the announcement by Sanofi and Verily, Onduo will “leverage Verily’s experience in miniaturized electrics, analytics, and consumer software development, and Sanofi’s clinical expertise and experience in brining innovative treatments to people living with diabetes.” The announcement also mentioned that Onduo will initially focus on the type 2 diabetes community, specifically on “developing solutions that could help people make better decisions about their day to day health, ranging from improved medication management to improved habits and goals.”
Stefan Oelrich, head of diabetes at Sanofi, said to the Wall Street Journal that the collaboration between Verily and Sanofi could yield a new product much faster than traditional drug development. He expected Onduo to launch its first product within 2 to 3 years, compared to the roughly 10 years it takes to develop a new medicine.
The joint venture came out about a year after Sanofi and Verily agreed to collaborate to improve care and outcomes for people with type 1 and type 2 diabetes. Onduo is one of many joint ventures that Verily have created in collaboration with other major pharmaceutical and medical device companies, including Galvani Bioelectronics, a joint venture with GlaxoSmithKline (GSK), and Verb Surgical, a joint venture with Johnson & Johnson’s Ethicon.
Sanofi and Verily appointed Joshua Riff, formerly a senior vice president of prevention and well-being at UnitedHealth Group’s Optum, as the chief executive officer of Onduo. The joint venture is based in Kendall Square, Cambridge, MA.
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices.
The draft guidance defines patient-specific information as “any information unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of a medical device, may be recorded, stored, processed, retrieved, and/or derived from that medical device.” According to the guideline, patient-specific information include recorded patient data, device usage/output statistics (e.g., pulse oximetry data, heart electrical activity, and rhythms as monitored by a pacemaker), healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures. Patients may contact their healthcare providers or manufacturers to obtain access to patient-specific information.
According to the draft guideline, manufacturers may share patient-specific information with a patient at the patient’s request without obtaining additional premarket review. The Health Insurance Portability and Accountability Act (HIPAA) and the associated HIPAA Privacy Rule intend to prevent manufacturers from sharing individually identifiable health information with covered entities (e.g., health plans, healthcare clearinghouses, and healthcare providers that electronically transmit health information) without the patient’s consent. However, the draft guideline opines that HIPAA and the HIPAA Privacy Rule are not intended to prevent a medical device manufacturer from sharing patient-specific information with the affected patient.
1. Considerations When Sharing Patient-Specific Information
In the draft guideline, FDA recommends that device manufacturers should take certain considerations into account when sharing patient-specific information. These considerations relate to the content of information provided, the context in which patient information from medical devices should be understood, and the need for access to additional, follow-up information from the manufacturer or a healthcare provider.
FDA recommends that a manufacturer take appropriate measures 1) to ensure that the information provided is interpretable and useful to the patient and 2) to prevent the disclosure of confusing or unclear information that could be misinterpreted. For example, the manufacturer may provide supplementary instructions, materials, or references to aid patient understanding. Patient-specific information provided to patients should be comprehensive and contemporary.
When providing patient-specific information to the affected patient, it may be appropriate for the device manufacturer to include relevant context in order to avoid circumstances where this information may be misinterpreted, thus leading to incorrect or invalid conclusions. Informing patients about how parameters were measured and recorded by the medical device is a good example of providing relevant context.
- Access to follow-up information
Manufacturers should consider what, if any, information they should include about whom to contact for follow-up information. The FDA recommends, at a minimum, that such manufacturers advise patients to contact their healthcare providers if the patients have any questions about their patient-specific information. Moreover, FDA suggests that manufacturers provide their contact information to answer questions from patients about the device at issue.
Comments and suggestions for the draft guideline are open for 60 days from its publication.
2. Implications on the Medical Device Industry
FDA opined in its draft guidance that device manufacturers’ disclosure of patient-specific information with the affected patient would be subject neither to additional premarket review by FDA nor to the HIPPA and the associated Privacy Rule.
On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. According to a press release by the manufacturer Aspire Bariatrics, the AspireAssist System is an endoscopic alternative to weight loss surgery for people with moderate to severe obesity and is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.
The FDA news release summarized the procedure of installing and using AspireAssist as follows:
To place the [AspireAssist] device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed.
According to the FDA news release, the FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy and 60 control patients who received only the lifestyle therapy. The lifestyle therapy included nutrition and exercise counseling. After one year, patients who used AspireAssist lost an average of 12.1 percent of their body weight compared to 3.6 percent for the control patients. Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life.
A youtube video on the AspireAssist System published by Aspire Bariatrics is attached below:
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine. Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill., that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders.
According to press releases, the PROLIFT system is the latest addition to the company’s platform of expandable interbody technologies. According to Life Spine, PROLIFT is an all-titanium system restores disc height, in-situ, for minimally invasive Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF) and oblique approaches. Once implanted, the system can expand cephalad to caudal to accommodate disc height ranges from 8mm to 16mm for varying patient anatomy.
According to Life Spine, “When paired with the CENTERLINE™ Midline Thoracolumbar Screw System, PROLIFT creates the optimal hyper-minimally invasive solution.” “The PROLIFT Expandable Interbody System allows for simplified, contracted insertion with minimal anatomical disruption and retraction,” said Rich Mueller, Chief Operating Officer of Life Spine.
Life Spine plans to launch a limited release of the PROLIFT system in the second quarter of 2016, and full product release is expected later in the year.
The New York Times reports that Congress has passed a $1.8 trillion package of spending and tax cuts which includes a two-year-long suspension of the medical device tax and a permanent extension of the research and experimentation tax credit (R&D tax credit). This came after an agreement between Republican and Democratic negotiators in the House reached on Tuesday, December 15, 2015. Shortly after its passage by Congress, President Obama signed the bill into law. Under the spending and tax measure, the medical device tax will be suspended for 2 years through the end of 2017, effective January 1, 2016.
According to a press release from Rep. Erik Paulsen (R-MN), the medical device tax was initially passed in the Affordable Care Act in 2010 and took effect in 2013. The Affordable Care Act imposed 2.3% excise tax on the sale of a diverse range of medical devices including pacemakers, ventilators, and artificial hips. The medical device tax has received significant criticism for the burden it placed on new entrants to and small players in the medical device space. Discussion regarding its repeal have been ongoing for quite some time.
In a joint press release, medical device industry groups including the Medical Device Manufacturers Association (MDMA), Advanced Medical Technology Association (AdvaMed), and Medical Imaging & Technology Alliance (MITA) applauded Congress for passage of the two-year suspension of the medical device excise tax in year-end legislation.
The R&D tax credit was originally introduced in the Economic Recovery Act of 1981 and has been temporarily extended since then. According to a press release issued by the Aerospace Industries Association, the most recent R&D tax credit extension lapsed at the end of 2014. Rep. Scott Peters (D-CA) lauded the permanent extension of the R&D tax credit and pointed out that: “with the credit made permanent, innovators know they can rely on this tax incentive to invest in their ideas.”
According to the Indications for Use Statement and the 510(k) Summary, Vera is a software system that uses the Microsoft Kinect technology to support physical rehabilitation of adults in the clinic and at home. The 510(k) submission states that the Microsoft Kinect Sensor uses structured infrared light to determine the position of objects in its field of view in three dimensions including distance, or “depth,” from the sensor.
Reflexion’s FDA submission also notes that the Vera software provides medical professionals the tools to record video and track movements in 3D space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise.
The 510(k) submission further states that, more specifically, the Vera system includes rehabilitation exercises for legs with audio-visual feedback and graphic movement representations for patients, as well as remotely accessible patient performance videos. Patient assessment, exercise guidance, and approval by a medical professional are required prior to use.
According to the Company’s website, Reflexion is currently partnering with the Cleveland Clinic and the Brooks Rehabilitation Center in Jacksonville, Florida to deliver Vera to patients recovering from joint replacement surgeries. A press release from the Brooks Rehabilitation Center regarding the partnership can be found here. A demonstrative picture from the press release is shown above. According to another press release, Reflexion has also received a $1 million grant from the Centers for Disease Control and Prevention to use Vera in fall prevention for seniors. As part of this grant, the technology is currently employed in two senior populations in San Diego, California and Fearrington, North Carolina. A video of the Vera software can be accessed below.